Pfizer
Eyes, mouth & ears symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | eye twitching |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2021-01-01 | ear itchiness |
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad...
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Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
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| 40 | 2021-01-03 | vision blurred |
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ...
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Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
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| 40 | 2021-01-04 | swelling around the eyes |
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4...
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Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-04 | loss of smell, loss of taste | Headache congestion clear nasal discharge throat pain and inflamation no smell no taste |
| 40 | 2021-01-04 | taste impairment | Headache, nausea, metalic taste, general malaise, low back pain |
| 40 | 2021-01-04 | mouth tingling |
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join...
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Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
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| 40 | 2021-01-04 | mouth numbness |
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ...
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Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
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| 40 | 2021-01-04 | mouth tingling, mouth numbness |
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h...
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Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 40 | 2021-01-04 | lip swelling, tongue itchiness |
Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all sympt...
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Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.
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| 40 | 2021-01-04 | ear discomfort | Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea |
| 40 | 2021-01-04 | ringing in ears |
bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-o...
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bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-01-04 | eye pain, sensitivity to light |
eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report fr...
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eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-05 | taste disorder |
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t...
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Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
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| 40 | 2021-01-05 | visual impairment |
I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circl...
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I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.
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| 40 | 2021-01-05 | mouth tingling |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-05 | mouth tingling |
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea...
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Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
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| 40 | 2021-01-05 | inability to speak |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-06 | lip swelling, mouth numbness |
Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contacta...
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Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 40 | 2021-01-07 | swollen tongue |
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re...
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Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
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| 40 | 2021-01-07 | ringing in ears |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | ear pain |
Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom ...
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Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.
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| 40 | 2021-01-07 | swollen tongue, mouth tingling |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | mouth tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue a...
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Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.
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| 40 | 2021-01-07 | mouth numbness, pain in jaw, ear pain |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | tongue discomfort |
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ...
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bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
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| 40 | 2021-01-08 | pain in jaw |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | hearing loss, mouth tingling, feeling of choking |
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE...
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11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
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| 40 | 2021-01-09 | lip swelling, eye swelling |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-09 | tongue itchiness |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | toothache, pain in jaw |
headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, ...
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headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA
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| 40 | 2021-01-10 | taste impairment |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | swollen tongue | Tongue swelling, headache, tachycardia, elevated BP |
| 40 | 2021-01-11 | eye swelling, eye irritation | Left eye feels full, swollen, chills. |
| 40 | 2021-01-11 | eye pain | PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD |
| 40 | 2021-01-12 | lip swelling |
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vacc...
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drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
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| 40 | 2021-01-12 | burning mouth syndrome, ear pain |
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we...
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heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
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| 40 | 2021-01-13 | eye swelling, mouth swelling, mouth numbness |
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle...
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In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
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| 40 | 2021-01-13 | taste impairment |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-13 | vision blurred |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
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| 40 | 2021-01-13 | mouth tingling |
developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved up...
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developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home
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| 40 | 2021-01-14 | dry mouth |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | visual impairment |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-14 | feeling of choking | Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning. |
| 40 | 2021-01-14 | oropharyngeal discomfort, ear discomfort |
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing...
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I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
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| 40 | 2021-01-14 | sensitivity to light |
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause...
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within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
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| 40 | 2021-01-15 | mouth numbness, lacrimation increased, taste impairment |
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ...
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Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
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| 40 | 2021-01-17 | eye movement disorder |
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled ...
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employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.
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| 40 | 2021-01-18 | swollen tongue, loss of taste, mouth numbness, taste impairment, mouth swelling |
Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue starte...
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Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.
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| 40 | 2021-01-18 | eye discomfort, eye pain |
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da...
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after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
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| 40 | 2021-01-19 | loss of smell, loss of taste |
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smel...
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1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
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| 40 | 2021-01-19 | pain in jaw |
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le...
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Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-20 | inability to speak | Fever, chills, headache, body aches, tired and loss of voice |
| 40 | 2021-01-20 | mouth numbness |
I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof o...
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I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof of mouth, tongue) feel numb. It is a little better, however, I still have numbness around my mouth and tongue. I don?t know if I should receive the second dose.
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| 40 | 2021-01-20 | bloodshot eyes, eye pain |
Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approxima...
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Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.
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| 40 | 2021-01-21 | mouth numbness |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-22 | mouth tingling |
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak...
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Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
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| 40 | 2021-01-23 | eye swelling | Got vaccine around 12pm on 1/23/21 Woke up on 1/24/21 around 9am with very swollen eyes |
| 40 | 2021-01-24 | mouth numbness, feeling of choking, mouth tingling |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-25 | mouth tingling |
1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reac...
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1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired. She stated "I feel fine"
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| 40 | 2021-01-25 | swollen tongue | On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches |
| 40 | 2021-01-26 | mouth tingling |
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap...
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About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
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| 40 | 2021-01-26 | sensitivity to light, eye pain, bloodshot eyes |
I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I a...
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I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I am being treated with prednisolone drops and a dilating eye drop. My symptoms have improved significantly with the eye drops. I do not know if this is at all related to the vaccine - I have a h/o one other episode of anterior uveitis in my L eye in 2004, felt to be HLA-B27 associated - however I figure it is worth reporting just in case.
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| 40 | 2021-01-26 | ear pain |
Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away...
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Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.
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| 40 | 2021-01-26 | swollen tongue |
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr...
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heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
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| 40 | 2021-01-27 | ear pain, extreme sound sensitivity |
Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while re...
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Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
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| 40 | 2021-01-27 | mouth tingling | Complaint of tingling tongue that was unfounded on exam. |
| 40 | 2021-01-27 | eye movement disorder |
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,...
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Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
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| 40 | 2021-01-27 | sensitivity to light |
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;...
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weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-28 | bloodshot eyes |
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too...
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Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
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| 40 | 2021-01-28 | feeling of choking |
Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease....
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Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease. Went back to work at unit. Has history of anaphylaxis to certain medications and ADR to TDaP
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| 40 | 2021-01-30 | mouth tingling, mouth discomfort |
patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observ...
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patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observation period; patient denies any additional symptoms; states that she had this same symptom after her first vaccination and that it lasted for about 1 hour
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| 40 | 2021-01-31 | eye pain |
I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis ...
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I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.
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| 40 | 2021-01-31 | mouth tingling |
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. ...
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Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
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| 40 | 2021-01-31 | pain in jaw, mouth pain, toothache | Severe headache - mostly top front of head radiating to mouth (teeth/jaw). |
| 40 | 2021-01-31 | mouth tingling, mouth numbness |
She pretreated with Claritin and tums. About 20 minutes after the injection she began having tinglin...
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She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.
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| 40 | 2021-01-31 | swelling of eyelid, eye pain, eye swelling |
left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; ...
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left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-02-01 | mouth numbness |
Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the f...
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Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
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| 40 | 2021-02-01 | eye irritation |
I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for...
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I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for COVID January 3rd, 2021; On January 1 mild headache; tired and very congested but then real runny nose (went back and forth). On January 2, I got a fever - 101. Took Tylenol. On January 3, I got a fever. I was taking zinc; vitamins. My doctor prescribed medicine but I only took it twice as I didn't like how it made me feel - made it feel like I had something in back of my throat. I still have headaches - they aren't going away and neither is the tiredness. Yesterday, I woke up fine - but when I was at work started feeling very tired; and headache was so bad it felt like eyes were burning. Today I had a mild headache. I was staying at a hotel until the tests for COVID came back negative. I normally don't have headaches and fatigue.
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| 40 | 2021-02-01 | mouth numbness, vision blurred |
Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed...
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Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours
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| 40 | 2021-02-02 | eye swelling |
angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelli...
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angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.
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| 40 | 2021-02-03 | loss of taste, loss of smell, ringing in ears |
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond...
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December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
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| 40 | 2021-02-03 | lip swelling, swelling of eyelid |
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne...
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Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
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| 40 | 2021-02-03 | swollen tongue | Tongue had blisters on edges and tip and swollen. Reports of it feeling scalded. |
| 40 | 2021-02-04 | eye pain |
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey...
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Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-06 | visual impairment |
15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred o...
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15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.
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| 40 | 2021-02-07 | mouth tingling |
25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swo...
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25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.
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| 40 | 2021-02-07 | taste impairment |
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,...
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Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
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| 40 | 2021-02-08 | ear discomfort |
Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and s...
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Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and sinus congestion that was present since 2/7/21.
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| 40 | 2021-02-09 | swollen tongue, dry mouth |
5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heart...
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5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high
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| 40 | 2021-02-09 | mouth tingling |
Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I though...
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Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.
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| 40 | 2021-02-09 | burning mouth syndrome, swollen tongue |
administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen a...
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administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen and tenderness in tongue; Swollen and tenderness in tongue; Tender gums; soreness on right side of neck under ear; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female patient received second dose of bnt162b2 (lot number: EL3246), intramuscularly at arm left on 22Jan2021 15:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EH9899) intramuscularly at left arm on 30Dec2020 15:00 for covid-19 immunisation. Not Pregnant at the time of vaccination. The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and tenderness in tongue. Tender gums and soreness on right side of neck under ear, from 24Jan2021 08:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Prednisone and Pepcid. The outcome of the events was recovering.
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| 40 | 2021-02-09 | vision blurred, visual impairment |
blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at inj...
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blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site
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| 40 | 2021-02-09 | dry mouth, thirst, mouth tingling |
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t...
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uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
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| 40 | 2021-02-14 | taste disorder |
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w...
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red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
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| 40 | 2021-02-15 | thirst | Extreme thirst for 3 days; Extreme energy/hyperactivity for 2 days; Insomnia for 3 nights |
| 40 | 2021-02-18 | eye swelling, eye pain |
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain...
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24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
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| 40 | 2021-02-21 | mouth tingling |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | mouth numbness |
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da...
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After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
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| 40 | 2021-02-22 | taste disorder |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-22 | vision blurred |
Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memor...
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Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.
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| 40 | 2021-02-23 | mouth tingling |
Following the injection, after approximately four hours later I began to feel some slight disorienta...
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Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
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| 40 | 2021-02-23 | ear pain | Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills. |
| 40 | 2021-02-23 | swollen tongue, tongue itchiness, lip swelling, lip itchiness | Swelling and itchiness of the upper lip and tongue about 10 minutes after the vaccination. |
| 40 | 2021-02-23 | mouth numbness | Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too |
| 40 | 2021-02-24 | mouth numbness |
40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat ,...
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40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.
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| 40 | 2021-02-26 | ear itchiness |
My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and e...
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My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose
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| 40 | 2021-02-28 | mouth numbness, feeling of choking |
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte...
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About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
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| 40 | 2021-02-28 | gaze palsy |
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant;...
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Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.
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| 40 | 2021-02-28 | eye irritation |
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ...
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Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
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| 40 | 2021-02-28 | taste disorder |
taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a sponta...
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taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264: expiry date: unknown) via an unspecified route of administration in the right arm, on 27Jan2021 at 14:45, at a single dose, for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included metoprolol and duloxetine hydrochloride (CYMBALTA). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place where vaccine was administered was reported as "other". On 27Jan2021, about 7 hours post injection, the patient's taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter). A full 24 hours after first injection, taste was still altered. The event was considered non-serious. The patient did not receive therapy for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 40 | 2021-03-02 | ear pain, eye irritation |
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve...
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Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
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| 40 | 2021-03-02 | taste impairment, mouth tingling |
Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of me...
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Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.
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| 40 | 2021-03-03 | lip itchiness |
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo...
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Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
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| 40 | 2021-03-03 | swollen tongue |
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience t...
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Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
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| 40 | 2021-03-03 | mouth numbness |
Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at sid...
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Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at side. Pt and mother left site to go home when pt told mother "my lips feel numb". Mother drove pt back to facility and came in to tell us that her daughter was in the car and c/o mouth feeling numb. Myself, Site Leader and charge nurse went outside to car. Pt was sitting on passenger side of car A/Ox3. Denies feeling sob, headache and chest pain. V/s obtained with inital v/s b/p 118/84, HR 83 O2 98% on RA. Advice pt that we could call EMS for further evaluation. Pt refused. Wanted to go home and take benadryl if numbness presist. Verbalized understanding of risk and outcomes of monitoring any other adverse symptoms.
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| 40 | 2021-03-03 | swollen tongue, lip swelling |
lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, sol...
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lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV
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| 40 | 2021-03-04 | vision blurred, sensitivity to light |
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi...
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After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
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| 40 | 2021-03-04 | oropharyngeal discomfort |
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP ...
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shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
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| 40 | 2021-03-05 | ringing in ears, eye strain |
8 minutes after the administration of the vaccine (while in the observation area) I started to feel ...
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8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
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| 40 | 2021-03-05 | eye itchiness |
Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of ana...
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Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.
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| 40 | 2021-03-07 | vision blurred | Dizziness, blurry vision, took oral Tylenol. BPs 98/68 (pulse 58), 97/66 (pulse 59). |
| 40 | 2021-03-07 | loss of smell |
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous...
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chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 40 | 2021-03-08 | ear pain |
Pain in back started then spread to right side and chest in about a week, called doctor's office and...
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Pain in back started then spread to right side and chest in about a week, called doctor's office and they said to report as a side effect of COVID vaccine. That pain has lessened but not completely gone. Ear pain started on 3/7/21, ear pain lessened after 24 hours but not completely gone.
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| 40 | 2021-03-09 | sensitivity to light, tongue disorder |
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt v...
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A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
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| 40 | 2021-03-09 | vision blurred | blurred vision, diaphoresis, hypotension, placed in trendelburg position |
| 40 | 2021-03-09 | bloodshot eyes |
this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbin...
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this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbing her eye, foreign body, or coughing or sneezing or force. instructed not likely related but asked to call back if worsening, vision loss, or blurred vision. wash hands well after touching face. call back prn.Followed up with patient today. She said that the red blotch in her eye is still there but not as red and can tell that it is going away. It doesn't bother her. She did contact her PCP and they told her that it is likely not related. She thanked me for my call. Will close case.
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| 40 | 2021-03-09 | mouth numbness | tongue numbness, headache and shortness of breath |
| 40 | 2021-03-10 | mouth numbness |
20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then r...
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20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.
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| 40 | 2021-03-10 | dry throat |
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start...
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About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
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| 40 | 2021-03-12 | taste impairment |
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I...
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Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
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| 40 | 2021-03-12 | vision blurred |
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ...
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Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
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| 40 | 2021-03-13 | tongue discomfort |
Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like ...
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Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.
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| 40 | 2021-03-14 | mouth tingling | Tingling in mouth and tongue. |
| 40 | 2021-03-16 | mouth tingling |
Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and ...
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Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and an increase in salivation. Able to speak in long sentences. Instructed to increase her fluid intake, use mints to her secretions and if it worsens or she notice any lip swelling or resp distress, to report to the nearest ER. RN
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| 40 | 2021-03-16 | vision blurred | Fever/chills, intense body aches, headache, occular blurring, muscle weakness, loss of appetite |
| 40 | 2021-03-17 | swollen tongue |
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid...
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Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
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| 40 | 2021-03-18 | mouth itchiness, swollen tongue |
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t...
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I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
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| 40 | 2021-03-18 | feeling of choking, mouth tingling |
My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic ...
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My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.
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| 40 | 2021-03-18 | ringing in ears |
Ringing in ears. The first time it happened I woke up and thought the sound was external, and I wok...
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Ringing in ears. The first time it happened I woke up and thought the sound was external, and I woke up my husband who said he didn?t hear anything. I realized at that point it?s the ringing in my ears. I hear it more at night time.
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| 40 | 2021-03-18 | ringing in ears |
Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my e...
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Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my ears which has not resolved.
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| 40 | 2021-03-18 | ringing in ears | Tinnitus |
| 40 | 2021-03-18 | lip swelling, swollen tongue |
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa...
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Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
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| 40 | 2021-03-19 | ringing in ears |
I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a car...
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I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.
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| 40 | 2021-03-19 | taste impairment |
Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness la...
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Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia
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| 40 | 2021-03-19 | swelling of eyelid |
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,...
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Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
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| 40 | 2021-03-19 | taste impairment |
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pati...
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Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
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| 40 | 2021-03-20 | loss of taste |
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up ...
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The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?
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| 40 | 2021-03-20 | hearing loss, ringing in ears |
This report is in relation to acute sudden onset tinnitus in left year one day following first shot ...
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This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.
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| 40 | 2021-03-21 | eye pain, vision blurred, sensitivity to light |
About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye ...
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About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye was painful and got worse over the course of three days. I went to the eye doctor and they diagnosed Iritis in my left eye. Sensitive to light and darkness and it was very painful. I was prescribed Steroids and it took two weeks before my vision improved and the pain was lessened. It took six weeks of Steroids before the condition was resolved. No symptoms after the second dose.
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| 40 | 2021-03-21 | mouth tingling, mouth numbness | Felt numbing/tingling on and around lips. Lasted about 30 minutes then went away |
| 40 | 2021-03-21 | ear pain, ear discomfort |
Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week...
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Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.
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| 40 | 2021-03-22 | ringing in ears | Constant Tinnitus with spiking attacks, non-stop |
| 40 | 2021-03-22 | pain in jaw | High fever, 102.5. Headache, joint pain (specifically jaw and knees), lethargy, chills |
| 40 | 2021-03-22 | mouth numbness |
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. C...
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Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.
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| 40 | 2021-03-22 | mouth tingling |
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ...
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Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
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| 40 | 2021-03-23 | dry mouth |
Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area a...
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Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.
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| 40 | 2021-03-24 | mouth tingling, lip swelling |
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo...
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03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
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| 40 | 2021-03-24 | mouth itchiness, swollen tongue |
11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness a...
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11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm
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| 40 | 2021-03-24 | vision blurred, gaze palsy |
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa...
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2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
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| 40 | 2021-03-24 | tunnel vision |
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self...
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Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
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| 40 | 2021-03-25 | tongue discomfort | Burning at tip of tongue without swelling and whole body feeling hot |
| 40 | 2021-03-25 | eye twitching |
Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine sympto...
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Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine symptoms in right eye.
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| 40 | 2021-03-25 | dry throat | Dry throat, cough. BP 133/88 (pulse 61). |
| 40 | 2021-03-25 | swollen tongue |
Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine,...
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Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram
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| 40 | 2021-03-26 | swelling of eyelid |
4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not s...
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4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.
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| 40 | 2021-03-26 | toothache |
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati...
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After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
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| 40 | 2021-03-27 | swollen tongue |
Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swellin...
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Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.
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| 40 | 2021-03-27 | loss of taste |
Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you a...
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Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.
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| 40 | 2021-03-27 | lip swelling |
lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lip...
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lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.
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| 40 | 2021-03-28 | deafness, hearing loss, ringing in ears |
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202...
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On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
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| 40 | 2021-03-29 | eye swelling |
Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous repor...
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Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
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| 40 | 2021-03-30 | ear pain |
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t...
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Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
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| 40 | 2021-03-30 | toothache |
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve...
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Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
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| 40 | 2021-03-30 | vision blurred |
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the...
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Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
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| 40 | 2021-03-30 | mouth tingling, taste impairment, eye irritation |
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; m...
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sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
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| 40 | 2021-04-03 | ringing in ears |
Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous rep...
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Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous report from a contactable physician (patient). A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283) first dose via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included iron supplement (SPATONE IRON supplement) for unspecified indication. On 14Feb2021 the patient experienced constant bilateral tinnitus, with attacking episodes multiple times a day (tinnitus) (disability). Therapeutic measures were taken as a result of constant bilateral tinnitus included prednisone taper. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not underwent diagnosed with COVID-19. After the vaccination patient did not tested for COVID-19. The outcome of the events was not recovered.
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| 40 | 2021-04-08 | lip swelling |
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio...
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Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
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| 40 | 2021-04-09 | eye movement disorder |
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ...
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Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
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| 40 | 2021-04-12 | lip swelling |
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati...
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had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
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| 40 | 2021-04-15 | eye pain |
Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 day...
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Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.
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| 40 | 2021-04-17 | eye strain |
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d...
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Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
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| 40 | 2021-04-21 | eye swelling, dry throat |
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,...
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throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
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| 40 | 2021-04-24 | swollen tongue, lip swelling |
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ...
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anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
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| 40 | 2021-04-26 | ringing in ears | Numbness on both sides of my face, fluttering feeling in brain and tinnitus in both ears |
| 40 | 2021-04-26 | vision blurred |
Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred v...
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Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 40 | 2021-04-28 | eye discomfort, taste disorder |
1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered tas...
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1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.
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| 40 | 2021-05-02 | vision blurred, ringing in ears |
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in bo...
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Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.
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| 40 | 2021-05-05 | swollen tongue, lip swelling, mouth tingling, tongue itchiness |
Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy...
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Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.
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| 41 | 2021-01-01 | mouth tingling, mouth numbness | perioral tingling, numbness |
| 41 | 2021-01-03 | lip swelling, swelling of eyelid |
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo...
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12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
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| 41 | 2021-01-03 | taste disorder, taste impairment |
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ...
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Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
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| 41 | 2021-01-04 | mouth tingling |
At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area ...
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At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination. RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink. Employee was alert and oriented. She reported slight reaction about 30min. post vaccination. Dr. was notified and assess the employee. Dr. ordered Benadryl 25mg PO at 1001. This was administered by RN. Employee was monitored for another 20 minutes and then was aloud to leave. Employee was feeling better before leaving. She was instructed to seek medical attention if symptoms returned or new symptoms occured. She verbalized understanding.
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| 41 | 2021-01-04 | sensitivity to light |
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na...
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Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-04 | loss of smell, loss of taste |
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t...
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I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
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| 41 | 2021-01-04 | lip swelling |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-05 | lip itchiness, mouth tingling | Broke out in red rash on neck, chest and arms. Lips itchy and tinging. |
| 41 | 2021-01-05 | swollen tongue | TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT |
| 41 | 2021-01-05 | taste impairment |
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a conta...
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got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
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| 41 | 2021-01-06 | swollen tongue |
Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination....
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Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.
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| 41 | 2021-01-06 | pain in jaw, ear pain |
I Initially just had a sore left arm which felt better the next day. I woke up the morning after t...
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I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
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| 41 | 2021-01-06 | taste impairment | Metallic taste in mouth |
| 41 | 2021-01-06 | mouth tingling | PARATHESIA OF LOWER LIP |
| 41 | 2021-01-06 | ear discomfort |
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt...
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Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
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| 41 | 2021-01-07 | ringing in ears | Achy body, headache, ear ringing, chills and a temperature. |
| 41 | 2021-01-07 | swollen tongue |
Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported ...
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Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation
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| 41 | 2021-01-07 | oropharyngeal discomfort |
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something...
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Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
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| 41 | 2021-01-08 | mouth tingling, taste impairment, lip swelling, mouth numbness |
1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left hal...
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1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left half of tongue- tip only- went numb Injected with 50mg of Benadryl in my left upper thigh 2nd event: 4.5 to 5 hours later- Metallic taste returned {Liken to cold house key metallic taste} in center of tongue- width of 1-2 mm, taste lasted 30-45 seconds. Left side of lips went numb (upper and lower) with lower again feeling swollen. Left upper part of tongue again went numb. Took 25 mg tablet of Benadryl. Odd feeling in tongue lasted for a few days after vaccine.
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| 41 | 2021-01-08 | mouth tingling | Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins. |
| 41 | 2021-01-08 | mouth discomfort, tongue discomfort |
Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and pro...
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Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches
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| 41 | 2021-01-08 | swollen tongue |
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci...
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Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
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| 41 | 2021-01-08 | taste impairment |
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h...
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employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
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| 41 | 2021-01-09 | mouth swelling |
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m...
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About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
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| 41 | 2021-01-10 | swollen tongue, lip itchiness |
Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and chee...
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Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.
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| 41 | 2021-01-10 | mouth discomfort, mouth swelling |
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ...
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cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 41 | 2021-01-11 | loss of taste, loss of smell |
41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes a...
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41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.
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| 41 | 2021-01-11 | vision blurred |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-11 | toothache, ear pain |
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ...
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I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-11 | vision blurred, sensitivity to light, visual impairment |
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and dif...
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Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
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| 41 | 2021-01-11 | dry throat |
Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Be...
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Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl
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| 41 | 2021-01-12 | eye itchiness |
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ...
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24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
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| 41 | 2021-01-12 | dry eye, dry mouth | Excruciating headache, dry mouth and eyes, Nausea and vomiting |
| 41 | 2021-01-12 | mouth numbness, feeling of choking |
POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP:...
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POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP: 143/91, O2 SAT R.A.: 98%; P: 78. 1435: VS: 144/88; 02 SAT R.A.: 98%; P: 78; 1440: LEFT SITE, NO OTHER COMPLAINTS.
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| 41 | 2021-01-12 | tunnel vision |
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre...
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Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
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| 41 | 2021-01-12 | eye itchiness, eye pain |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
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| 41 | 2021-01-13 | ringing in ears |
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm...
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1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
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| 41 | 2021-01-13 | mouth tingling |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | mouth tingling, taste disorder |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | ringing in ears |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | loss of taste |
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a...
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Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
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| 41 | 2021-01-13 | mouth numbness, mouth tingling |
Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/l...
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Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
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| 41 | 2021-01-13 | mouth tingling |
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324...
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Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
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| 41 | 2021-01-13 | eye pain |
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu...
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Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
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| 41 | 2021-01-13 | lip swelling | swollen lip |
| 41 | 2021-01-14 | mouth itchiness, tongue itchiness, lip itchiness, lip swelling, mouth swelling |
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu...
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About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
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| 41 | 2021-01-14 | dry mouth |
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i...
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Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
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| 41 | 2021-01-14 | sensitivity to light |
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join...
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Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
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| 41 | 2021-01-14 | feeling of choking, mouth tingling | Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety |
| 41 | 2021-01-14 | toothache, pain in jaw | Tooth pain across the entire lower jaw that lasted for about 18 hours. Treated with ibuprofen. |
| 41 | 2021-01-14 | toothache, pain in jaw | Toothache across the entire lower jaw, which lasted for about 12 hours. Treated with ibuprofen. |
| 41 | 2021-01-14 | mouth numbness |
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ...
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Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
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| 41 | 2021-01-15 | tongue itchiness |
I started itching while being monitored post vaccine administration within the 5 minutes of the vacc...
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I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
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| 41 | 2021-01-15 | dry mouth |
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFi...
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Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
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| 41 | 2021-01-16 | oropharyngeal discomfort, pain in jaw |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-17 | ear itchiness, oropharyngeal discomfort |
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p...
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5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
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| 41 | 2021-01-17 | inability to speak |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | pain in jaw |
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain...
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Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
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| 41 | 2021-01-17 | ear pain, eye pain, swollen tongue, mouth pain, vision blurred |
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ...
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Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
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| 41 | 2021-01-17 | loss of smell | Sore arm, body aches, headache, cough, loss of smell |
| 41 | 2021-01-17 | dry mouth | headache, dry mouth, and arm pain |
| 41 | 2021-01-17 | vision blurred |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | eye itchiness, eye swelling |
22 hours after the second dose started to have an allergic reaction, hives all over back and chest a...
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22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
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| 41 | 2021-01-18 | eye swelling |
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/...
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5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
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| 41 | 2021-01-18 | swelling of eyelid, swollen tongue |
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop...
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Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
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| 41 | 2021-01-18 | swelling around the eyes, lip swelling, eye itchiness |
Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scrat...
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Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.
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| 41 | 2021-01-18 | vision blurred |
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f...
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Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
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| 41 | 2021-01-18 | lip swelling, taste impairment, mouth numbness |
tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a...
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tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (Right arm) first dose on 02Jan2021 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient experienced metallic taste, lower left lip felt swollen, and tip of tongue numb. The patient was treated with Injection 50 mg Benadryl L thigh. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not tested for COVID-19.
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| 41 | 2021-01-20 | oropharyngeal discomfort |
Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symp...
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Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work
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| 41 | 2021-01-20 | eye irritation, mouth tingling, eye twitching, eye pain, swelling around the eyes, eye swelling |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-21 | eye pain | I had eye pain and drainage, body aches, abdominal pain, headache and joint pain. |
| 41 | 2021-01-21 | vision blurred, eye discomfort |
Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injectio...
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Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."
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| 41 | 2021-01-21 | mouth tingling |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-21 | mouth tingling |
Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patie...
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Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.
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| 41 | 2021-01-21 | ear discomfort |
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-e...
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Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over
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| 41 | 2021-01-22 | mouth discomfort | Chest pain, lethargy, burning airway |
| 41 | 2021-01-22 | mouth numbness |
Numbness right side of throat, right side of tongue, right side of face and right side of neck. Sym...
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Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release
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| 41 | 2021-01-23 | mouth numbness, taste disorder |
Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient rep...
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Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient reports has no numbness and can't describe the taste but feels good and was able to go home instructions of any more or worsen symptoms to go ER
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| 41 | 2021-01-23 | mouth numbness |
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe...
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Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
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| 41 | 2021-01-24 | lip itchiness |
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given ...
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Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
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| 41 | 2021-01-24 | mouth tingling, swollen tongue |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-24 | swollen tongue |
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun...
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This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
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| 41 | 2021-01-25 | swollen tongue | Hives, itching, tongue swelling |
| 41 | 2021-01-25 | visual impairment | Itchy throat, sudden warmth, see spots, chest tightness. |
| 41 | 2021-01-25 | ear pain |
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma...
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Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
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| 41 | 2021-01-25 | mouth tingling, swollen tongue |
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the to...
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heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-01-26 | swollen tongue, mouth tingling |
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a...
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Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
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| 41 | 2021-01-26 | eye bleeding | Woke up on broken blood vessel in left eye: sub conjunctival hematoma |
| 41 | 2021-01-26 | blindness, visual impairment, deafness |
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o...
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seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-26 | mouth numbness |
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left...
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severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
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| 41 | 2021-01-26 | eye irritation |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-27 | mouth numbness, mouth tingling |
15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips...
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15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.
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| 41 | 2021-01-27 | mouth tingling |
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s....
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40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
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| 41 | 2021-01-27 | pain in jaw | Headache, Jaw pain/stiffness. |
| 41 | 2021-01-27 | ear pain |
I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed he...
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I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
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| 41 | 2021-01-27 | swollen tongue |
PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 1...
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PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.
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| 41 | 2021-01-27 | oropharyngeal discomfort |
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 mi...
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Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
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| 41 | 2021-01-27 | pain in jaw |
Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a...
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Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.
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| 41 | 2021-01-28 | eye itchiness |
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h...
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"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
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| 41 | 2021-01-28 | ear pain, ear discomfort |
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a...
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It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
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| 41 | 2021-01-28 | taste impairment |
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T...
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weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
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| 41 | 2021-01-29 | mouth numbness |
Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw ph...
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Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw physician who treated her with steroids, anti-virals and OTC eye drops for lubrication of eye.
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| 41 | 2021-01-30 | mouth discomfort, mouth swelling |
At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute ma...
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At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone
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| 41 | 2021-01-30 | swelling of eyelid |
Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the n...
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Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.
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| 41 | 2021-01-31 | sensitivity to light, vision blurred |
12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color,...
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12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color, altered depth perception, light sensitivity in right eye, 12/21/20: exam by opthalmologist (Dr), 12/23/20: MRI with and without contrast: showed active inflammation on right optic nerve, optic neuritis - referred to neuro opthalmologist, 12/29/20: examined by Dr. (neuro-opthalmologist), confirmed optic neuritis and referred to Dr. (neurologist) for further eval of possible MS, 01/18/21: virtual meeting with Dr., labs ordered. 02/01/21: no treatment to date and I am still experiencing all original symptoms, though have slightly improved since initial onset. Planned follow up with Dr. (neurologist) this week and follow up with Dr. (neuro-ophthalmologist) next week
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| 41 | 2021-02-01 | swollen tongue | 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack |
| 41 | 2021-02-01 | mouth numbness |
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani...
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Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
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| 41 | 2021-02-01 | swollen tongue |
Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose recei...
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Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.
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| 41 | 2021-02-03 | sensitivity to light, extreme sound sensitivity |
Both times I received the vaccine on the third day I my migraine was triggered and I experienced se...
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Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
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| 41 | 2021-02-03 | mouth numbness |
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his...
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Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
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| 41 | 2021-02-03 | oropharyngeal discomfort, inability to speak | My throat feels like its closing up, it doesn't feel very sore but my voice is very hoarse. |
| 41 | 2021-02-04 | lip swelling |
Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills;...
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Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-02-05 | feeling of choking, mouth tingling |
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachyca...
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Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
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| 41 | 2021-02-06 | ear pain |
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn...
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Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
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| 41 | 2021-02-08 | ear discomfort, ringing in ears |
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. ...
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Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.
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| 41 | 2021-02-08 | mouth tingling |
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a...
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I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
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| 41 | 2021-02-08 | mouth tingling |
Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine admin...
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Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine administration. Was evaluated in clinic and found to be AAOx3, NAD, nontoxic, no swelling of lips or tongue, lungs CTA with good air entry, regular rate and rhythm, given x1 dose of diphenhydramine and transported to the Emergency Center where she was evaluated again. Found to be in similar condition as above so given an additional 75 mg total of diphenhydramine. Sent home after short observation period.
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| 41 | 2021-02-09 | toothache |
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ...
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At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
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| 41 | 2021-02-09 | ear pain |
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This ...
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Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
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| 41 | 2021-02-09 | eye itchiness |
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen...
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Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-02-09 | ear pain |
States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 162...
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States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
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| 41 | 2021-02-10 | ringing in ears |
I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have...
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I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.
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| 41 | 2021-02-10 | mouth itchiness, ear itchiness | Itchy mouth, swollen face, itchy scalp, itchy ears |
| 41 | 2021-02-11 | pain in jaw, toothache, mouth pain |
About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within abo...
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About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation. It was like the roots of all the molars were irritated. The nerve sensation also felt like it was in the upper jaw/face area. My entire pallet became irritated. This lasted for about two hours and then went away completely.
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| 41 | 2021-02-15 | mouth numbness |
Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine ...
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Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.
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| 41 | 2021-02-21 | lip swelling | During the 15 minute observation period, pt reported upper lip swelling and hives on face. |
| 41 | 2021-02-21 | mouth tingling | Flushing, tachycardia, lip tingling |
| 41 | 2021-02-21 | swollen tongue, lip itchiness |
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu...
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itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
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| 41 | 2021-02-22 | eye itchiness, swelling around the eyes, mouth tingling |
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi...
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Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
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| 41 | 2021-02-24 | mouth discomfort |
About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burn...
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About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).
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| 41 | 2021-02-25 | ringing in ears |
Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance....
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Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
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| 41 | 2021-02-25 | tongue disorder |
Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received...
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Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.
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| 41 | 2021-02-26 | thirst |
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig...
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Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
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| 41 | 2021-02-27 | mouth numbness |
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s...
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Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
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| 41 | 2021-02-28 | thirst |
Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday mor...
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Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.
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| 41 | 2021-02-28 | double vision, visual impairment |
MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in ...
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MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-28 | ringing in ears | ringing/buzzing in ear, pain/heaviness, headache |
| 41 | 2021-03-01 | mouth tingling, oropharyngeal discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-01 | pain in jaw | Sore arm Jaw pain Skin sensitive on face Headache |
| 41 | 2021-03-01 | eye swelling |
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire....
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pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
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| 41 | 2021-03-02 | lip swelling |
My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin i...
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My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin it.
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| 41 | 2021-03-02 | mouth numbness |
On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakn...
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On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.
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| 41 | 2021-03-02 | mouth numbness, loss of taste |
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de...
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Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
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| 41 | 2021-03-02 | tongue disorder |
Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her ...
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Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off. on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck. Experienced dizziness and fatique in the morning.
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| 41 | 2021-03-02 | swollen tongue |
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o...
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Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
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| 41 | 2021-03-02 | eye itchiness, taste impairment |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-03 | mouth tingling, taste impairment |
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in...
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After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
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| 41 | 2021-03-03 | lip swelling |
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat...
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Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
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| 41 | 2021-03-03 | mouth tingling, mouth numbness |
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m...
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With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
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| 41 | 2021-03-04 | ear discomfort |
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th...
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Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
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| 41 | 2021-03-04 | mouth tingling, taste impairment |
Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21....
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Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM
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| 41 | 2021-03-06 | mouth tingling, taste impairment |
Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by...
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Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by medic on site.
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| 41 | 2021-03-07 | hearing loss |
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache...
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1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
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| 41 | 2021-03-07 | swollen tongue |
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti...
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At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
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| 41 | 2021-03-07 | lip swelling, eye swelling |
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief...
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o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
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| 41 | 2021-03-08 | oropharyngeal discomfort, eye irritation |
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,...
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Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
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| 41 | 2021-03-09 | vision blurred, taste disorder, lacrimation increased, ringing in ears |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-09 | swelling of eyelid |
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th...
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I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
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| 41 | 2021-03-10 | swollen tongue, oropharyngeal discomfort |
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T...
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ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
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| 41 | 2021-03-10 | mouth numbness |
She received the vaccine at 0930 and had itching her lips became numb shortly after starting around ...
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She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.
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| 41 | 2021-03-10 | mouth tingling | lips and tongue tingling, lump in throat. Evaluated by EMS-Cleared |
| 41 | 2021-03-11 | lip itchiness | Anaphylaxis, swollen throat, itchy lips, hives. |
| 41 | 2021-03-13 | lip swelling |
The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had J...
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The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had Juvederm lip injections for almost 2 years but had recently gotten a touch up on only my top lip last November of 2020. Bottom lip is fine. Consulted with my doctor. Took Benadryl and was prescribed Claritin and steroids.
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| 41 | 2021-03-14 | ear discomfort |
1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, ...
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1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.
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| 41 | 2021-03-14 | visual impairment |
A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw ...
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A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw an eye doctor for an emergency visit on Saturday, 3/13. He did a full exam with dilation, and suspects it is an optic neuritis. Today, I had a visual field test, but I am unaware of the results yet. There has been no improvement in my vision since Saturday when I saw the doctor.
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| 41 | 2021-03-14 | swollen tongue |
Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency te...
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Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency team called and arrived less than 10 minutes after call, they assessed and brought pt to ED. Pt's vitals were recorded & stable and information sheet given to ED team. Copy scanned into pt's chart.
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| 41 | 2021-03-15 | vision blurred |
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn...
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Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
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| 41 | 2021-03-15 | swelling of eyelid | very swollen eye lids for around 24-48 hours |
| 41 | 2021-03-18 | tongue discomfort, mouth discomfort |
I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two h...
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I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two hours in it felt like my tongue was increasingly getting heavier and heavier for around a 10 minutes timeframe. It then stopped but for two days it felt like I had burnt my tastebuds. Starting two days ago I have developed a red rash on my arms that burns at times and seems to come and go.
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| 41 | 2021-03-18 | loss of smell, loss of taste | Loss of smell and taste, body achy, nausea, |
| 41 | 2021-03-19 | oropharyngeal discomfort |
10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Th...
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10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Throat feels better. Shaky. 11:02 Transported
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| 41 | 2021-03-19 | mouth itchiness, tongue itchiness |
25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mo...
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25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mouth and tongue started to get itchy - went to see nurse : took 50mg Benadryl 40 minutes after vaccine shot: difficulty swallowing: need to clear throat 50 minutes after vaccine shot: nurse suggested taking my EpiPen but I was still able to breathe (all other symptoms were still very present Approximately 25-30 minutes after taking Benadryl symptoms began to subside. No EpiPen was administered. Approximately 95 minutes after vaccine shot: symptoms were reduced enough to go home.
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| 41 | 2021-03-19 | thirst, dry mouth | Dry mouth and thirst |
| 41 | 2021-03-20 | bloodshot eyes |
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face...
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Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
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| 41 | 2021-03-21 | eye pain, eye irritation |
Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed ...
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Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed with keratoconjunctivitis. The doctor said she has seen this in patients that receive the Covid shot.
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| 41 | 2021-03-21 | eye swelling | Swollen eyes burning skin jittery feeling |
| 41 | 2021-03-21 | ringing in ears | Tinnitus in left ear started less than 2 hours after vaccine and hasn?t let up since |
| 41 | 2021-03-22 | tunnel vision, ear discomfort |
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ...
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About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
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| 41 | 2021-03-22 | oropharyngeal discomfort, ear discomfort, burning mouth syndrome |
I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately ...
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I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately blistered up. The glands at the back of my tongue were inflamed, my epiglottis hurt and my esophagus hurt the whole way down to my stomach in my chest. My inner ears felt pressure and throbbed. By that night my whole tongue hurt and I couldn't touch anything to it. This reaction stayed like this for 2 days and each time I tried to eat anything -even soft foods like yogurt- the roof of my mouth blistered up. My esophagus and epiglottis felt damaged. I ended up not eating much for a couple of days due to the pain and reactions.
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| 41 | 2021-03-22 | mouth tingling |
Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; ...
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Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
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| 41 | 2021-03-22 | mouth tingling, taste impairment |
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec...
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Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
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| 41 | 2021-03-22 | mouth numbness | lip numbess and throat tightness |
| 41 | 2021-03-23 | vision blurred, ringing in ears |
3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN C...
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3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN CHAIR. A/O, PINK, W/D, RESP REG WITH EASE. PERLA. NO NEURO DEFICIT. GOOD MOTOR/SENSORY NOTED. COMFORT GIVEN. 4:17PM STATES SHE 'FEELS BETTER NOW'. 4:25PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO DISTRESS NOTED. 3-24-21 9:45AM PT STATES SHE 'FEELS MUCH BETTER'.
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| 41 | 2021-03-23 | lip swelling, mouth tingling, mouth numbness |
Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minut...
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Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
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| 41 | 2021-03-23 | ringing in ears |
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,...
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Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
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| 41 | 2021-03-24 | ear swelling |
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back...
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5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
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| 41 | 2021-03-24 | lip itchiness |
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "...
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RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
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| 41 | 2021-03-24 | double vision, vision blurred, ringing in ears |
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu...
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Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-03-24 | ringing in ears, vision blurred, visual impairment, lacrimation increased |
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an...
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Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-03-24 | feeling of choking | Tingling in throat and a little dizzy feeling-VSS-All resolved. |
| 41 | 2021-03-25 | mouth tingling |
3/26/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screenin...
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3/26/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness.. and tingling of the tongue Assessment : Time of assessment 1810. Alert and oriented.and anxious, no visual swelling, rash, or redness. Actions taken: Water offered and accepted, VS taken at 1810- BP- 160/94, P- 86, O2- 100%, recheck @ 1824 - BP- 149/101 Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. she was advise to follow up with PCP regarding BP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 5:52 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 41 | 2021-03-25 | dry mouth |
At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry...
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At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water. Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA. Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.
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| 41 | 2021-03-25 | mouth tingling, oropharyngeal discomfort, mouth numbness, feeling of choking |
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star...
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Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.
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| 41 | 2021-03-25 | ear discomfort, hearing loss |
Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so s...
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Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.
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| 41 | 2021-03-25 | vision blurred | Warm and tingly all over and blurry vision |
| 41 | 2021-03-26 | lip swelling | Lip swelling, throat pain, itching |
| 41 | 2021-03-26 | dry mouth, mouth tingling |
Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Pa...
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Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.
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| 41 | 2021-03-26 | ear pain | Right lymph node in neck swelling/pain. Right ear pain |
| 41 | 2021-03-31 | swollen tongue, eye itchiness, lip swelling, bloodshot eyes |
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens...
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Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
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| 41 | 2021-04-02 | mouth tingling, lip swelling, mouth numbness |
angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/ti...
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angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-04-10 | burning mouth syndrome, mouth pain |
Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER ...
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Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER April 10th, pins and needles and burning all over body for a full day period. Continuing to get worse. Have been referred to rheumatologist and neurologist, but no one knows what is going on or how to treat. Only tell me ?I am not the only one?. Feels like arthritis in hands. Pain mostly in mouth, tongue, spine, feet, legs.
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| 41 | 2021-04-13 | visual impairment |
Two weeks after getting the second dose of the vaccine, I had two episodes of vertigo. I have no hi...
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Two weeks after getting the second dose of the vaccine, I had two episodes of vertigo. I have no history of vertigo. I also developed bouncy vision where it looks like things are bouncing up and down or moving side to side when I walk or turn my head. It has not resolved. I am scheduled with a neurologist on 5/4/21 to determine if I have any vestibular damage. It is possible this is permanent and at this current time it is very disabling. I am not sure if this is related to the vaccine but I thought it best to report it in case other reports of this come up.
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| 41 | 2021-04-15 | visual impairment |
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp...
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he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
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| 41 | 2021-04-18 | mouth numbness |
Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms aro...
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Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering. Information about batch/lot number has been requested.
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| 41 | 2021-04-20 | eye bleeding, bloodshot eyes, eye swelling |
blood vessels in her left eye popped and eye looks bloody; Caller adds that it is gross; Caller adds...
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blood vessels in her left eye popped and eye looks bloody; Caller adds that it is gross; Caller adds that it looks like it is getting red, more red, it does not look like it is spreading but it is getting darker; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 05Apr2021 10:15 (Lot Number: ER8732) at age of 41 years old as single dose for covid-19 immunisation, alpha-1 antitrypsin deficiency, liver disorder, lung disorder. Medical history included ongoing alpha-1 antitrypsin deficiency, ongoing factor v leiden carrier, ongoing bipolar disorder, diabetes mellitus (she did not know if it meant anything but it turned out they were both very very diabetic. She adds this scares her, she does not want a needle), iron deficiency, vitamin d deficiency, lung disorder, emphysema, chronic obstructive pulmonary disease, hypertension, insomnia, depression, dumping syndrome and acid reflux. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was none. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for alpha-1 antitrypsin deficiency, emphysema, chronic obstructive pulmonary disease from an unspecified start date and ongoing; colestipol taken for dumping syndrome from an unspecified start date and ongoing; dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; iron taken for iron deficiency; lamotrigine (LAMICTAL) taken for bipolar disorder from an unspecified start date and ongoing; levomefolic acid (L-METHYLFOLATE) taken for depression from an unspecified start date and ongoing; lisinopril taken for hypertension; amlodipine besilate (NORVASC) taken for hypertension from an unspecified start date and ongoing; alpha-1-antitrypsin (PROLASTIN-C) taken for alpha-1 antitrypsin deficiency from an unspecified start date and ongoing (did not have dosage, she got an infusion into a port once a week. She got five bottles. She was on this for alpha-1, maybe 10 years); tiotropium bromide (SPIRIVA) taken for lung disorder, alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, emphysema from an unspecified start date and ongoing (Caller thinks it is a standard, it is once a day. She has been on for 10 years. It does not say anything else, it just says Spiriva handihaler); temazepam taken for insomnia; vilazodone hydrochloride (VIIBRYD) taken for bipolar disorder; colecalciferol (VITAMIN D3) taken for vitamin d deficiency; olanzapine (ZYPREXA) taken for bipolar disorder from an unspecified start date and ongoing; multivitamin (Dosage text: Caller takes one a day, it does not really have a dose, she does not see a dose thing on it. has been taking for about 20 years, Caller states she eats like crap). The patient got her first shot yesterday (05Apr2021), and then woke up with the blood vessels in her left eye were popped, and her whole eye looked bloody. She added this was kind of tripping. She wanted to know if this had anything to do with the shot (Pfizer Covid19 vaccine) or anything else. It was gross, and she did not like looking at it. It looked like there was blood around her eye, and it started when she woke up this morning it was like that. It looked like it was getting red, more red, it did not look like it was spreading but it was getting darker. She clarified and stated that it was a lot of pets. She did start an allergy drop a week and a half ago, Pataday (lot number 102C5, expiration date Dec20211, over the counter) eye drop; it was a 0.2 % antihistamine. Treatment reported as: just the Pataday eye drops, which were for allergies. She did not know what was up with the pollen this year but it was trying to kill her. She started these a week and a half ago. The events did not require a visit to Physician office or Emergency Room. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-04-21 | taste impairment |
I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improve...
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I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improved but I?m nervous now that it has lasted so long and I?m due for my second vaccine on April 27.
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| 41 | 2021-04-22 | swollen tongue |
Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a...
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Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
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| 41 | 2021-04-27 | swelling around the eyes |
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling ar...
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She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
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| 41 | 2021-04-28 | vision blurred, ringing in ears |
Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing lo...
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Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 41 | 2021-04-30 | swollen tongue |
arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; ...
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arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
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| 41 | 2021-04-30 | smell distorsion |
didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a sp...
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didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-05-07 | blindness |
Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracrania...
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Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracranial pressure with vision loss requiring VP shunt placement; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Jan2021 at 12:00 (Lot Number: EK9231)(at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, all from an unknown date and unknown if ongoing. Known allergies: KEFLEX, LEVAQUIN, Penicillin. Concomitant medication included levothyroxine; lisinopril; trazodone and HCTZ, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 04Jan2021 at 15:00 (Lot Number: EL0140) (at the age of 40-year-old) as single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient experienced increased intracranial pressure with vision loss requiring VP shunt placement. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events for 2 days. The patient underwent lab tests and procedures which included intracranial pressure (CSF pressure): increased on 26Jan2021, SARS-COV-2 test (Nasal Swab): negative on an unspecified date. Therapeutic measures were taken as a result of the events and included 3 lumbar punctures and surgery for VP shunt. The patient outcome of the events was recovering.; Sender's Comments: The 41-year-old patient had medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, and was on multiple concomitant medications. Intracranial pressure increased and blindness were most likely due to concurrent disease, and unlikely related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 41 | 2021-05-07 | ringing in ears, hearing loss |
This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old...
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This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital. Medical history was none. There were no concomitant medications. In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-05-09 | ringing in ears, deafness, ear discomfort | Clogged feeling in ears, hearing loss, tinnitus |
| 42 | 2021-01-01 | dry mouth, swollen tongue |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-03 | ear swelling |
Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down ...
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Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.
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| 42 | 2021-01-03 | deafness unilateral |
Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the ...
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Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-03 | lip swelling | Lip and facial area swelling tow days after receiving vaccine. |
| 42 | 2021-01-03 | oropharyngeal discomfort | Patient complained of shortness of breath, chest tightness, and throat closure |
| 42 | 2021-01-03 | swollen tongue |
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin...
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began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
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| 42 | 2021-01-04 | loss of smell |
Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable...
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Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
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| 42 | 2021-01-04 | loss of taste, taste disorder |
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of...
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Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
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| 42 | 2021-01-04 | visual impairment |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | loss of smell |
had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested ...
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had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient). A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020. The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.
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| 42 | 2021-01-04 | eye pain, visual impairment | infection in L nostril and pain radiating to L eye, impacting vision |
| 42 | 2021-01-04 | tongue disorder, mouth numbness |
throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a sponta...
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throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.
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| 42 | 2021-01-05 | mouth swelling |
had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within ...
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had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour
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| 42 | 2021-01-05 | oropharyngeal discomfort |
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ...
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she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-05 | mouth numbness | tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb |
| 42 | 2021-01-06 | lip swelling |
At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were sw...
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At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.
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| 42 | 2021-01-06 | ear pain, eye discomfort |
Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a he...
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Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.
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| 42 | 2021-01-07 | tongue itchiness, lip itchiness |
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait...
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After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
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| 42 | 2021-01-07 | thirst |
Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable othe...
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Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 42 | 2021-01-07 | mouth tingling |
Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged t...
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Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.
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| 42 | 2021-01-07 | mouth tingling |
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o...
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Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
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| 42 | 2021-01-09 | oropharyngeal discomfort | I HAD SUDDEN MILD THROAT DISCOMFORT DIFICULTY SWOLLOWING THAT NEVER WENT ALWAY. |
| 42 | 2021-01-10 | mouth numbness, mouth tingling, tongue disorder |
5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the t...
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5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the tingling progressed from the tip to the back of by tongue.
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| 42 | 2021-01-10 | eye swelling |
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, alon...
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Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
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| 42 | 2021-01-10 | swollen tongue, mouth tingling |
lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, cl...
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lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).
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| 42 | 2021-01-10 | taste impairment |
recipient had a metallic taste in her mouth after vaccine administration, states this had happen bef...
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recipient had a metallic taste in her mouth after vaccine administration, states this had happen before with other vaccines.
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| 42 | 2021-01-11 | eye pain |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | vision blurred |
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she...
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While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm". Â Pt stated that her heart felt like it was "pounding". Â VS: 162/96, 99% RA, HR in the 70's. Â Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home. Â The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist. Â Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications. Â
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| 42 | 2021-01-11 | eye irritation, taste impairment |
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face...
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Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
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| 42 | 2021-01-12 | taste impairment |
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro...
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1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
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| 42 | 2021-01-12 | eye swelling |
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ...
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1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
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| 42 | 2021-01-12 | mouth tingling, feeling of choking, mouth swelling, mouth numbness |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | loss of smell | Loss of smell |
| 42 | 2021-01-12 | mouth tingling |
Patient initially experienced tingling in left hand right after injection. This resolved but then sh...
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Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
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| 42 | 2021-01-12 | eye floaters |
The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a...
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The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a usual floatie that might come and go these have a shape that changes as I move my eye. There is no pain, they are a sudden annoyance that i hope will go away but I wanted to make sure I reported it.
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| 42 | 2021-01-12 | mouth tingling |
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM...
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Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
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| 42 | 2021-01-12 | mouth tingling |
patient experienced transient tingling of lips shortly after vaccine administration (within 15 minut...
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patient experienced transient tingling of lips shortly after vaccine administration (within 15 minutes but could not specify exact time after). Symptoms resolved on its own within 10 minutes of reporting to us (pharmacists). Declined oral diphenhydramine at time of reporting to us but said she would let us know if she had any changes. No further adverse events or symptoms returning >2 hours after initial report.
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| 42 | 2021-01-13 | dry mouth |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-14 | swollen tongue, lip swelling |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | lip swelling, mouth tingling, swollen tongue |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | lacrimation increased |
Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is...
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Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-14 | lip swelling |
My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my...
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My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my lips 2 years ago.
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| 42 | 2021-01-14 | feeling of choking |
Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and...
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Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am
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| 42 | 2021-01-15 | eye pain | Fever 101.8 Headache Pain behind eyes Aches Chills |
| 42 | 2021-01-16 | taste impairment |
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu...
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On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
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| 42 | 2021-01-17 | mouth discomfort |
10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shor...
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10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
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| 42 | 2021-01-17 | lip swelling, swollen tongue |
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,...
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About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
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| 42 | 2021-01-17 | mouth tingling |
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch...
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Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
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| 42 | 2021-01-17 | mouth numbness, mouth tingling |
Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administrat...
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Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administration. Pt has hx of multiple allergies. Pt was asked to take mask off and redness subsided within 5 mins. Pt then reported having numbness/tingling in tongue and lips. Pt was monitored for a total of 36 minutes per RN. Pt reported no further symptoms and noted improvement of symptoms. She was discharged to home with husband, who was also present for the event.
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| 42 | 2021-01-17 | eye pain, eye discomfort, ringing in ears |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-18 | deafness unilateral |
Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, a...
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Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, and I couldn?t hear out of my left ear. These symptoms peaked approximately 12 hours after the vaccine. They lasted for 24 hours. The next day, the fever was gone and the only symptom I had was fatigue. 48 hours after the vaccine all my symptoms had resolved.
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| 42 | 2021-01-18 | loss of taste, loss of smell |
Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste ...
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Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste on Tuesday which lasted until Thursday
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| 42 | 2021-01-18 | taste impairment | c/o tingling of face and tongue, metallic taste |
| 42 | 2021-01-18 | eye swelling |
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi...
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mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 42 | 2021-01-19 | swollen tongue |
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:...
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5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
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| 42 | 2021-01-19 | vision blurred |
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throa...
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About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
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| 42 | 2021-01-19 | taste impairment |
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting...
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EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
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| 42 | 2021-01-19 | taste impairment |
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid...
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Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
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| 42 | 2021-01-19 | sensitivity to light |
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until...
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Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
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| 42 | 2021-01-19 | mouth tingling | Small hives around neck, face, tingling in lips. |
| 42 | 2021-01-21 | ringing in ears | Body aches, chills, headache, dizziness, ringing in the ears, nausea, vomiting, and fatigue |
| 42 | 2021-01-21 | sensitivity to light |
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of...
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Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.
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| 42 | 2021-01-23 | mouth tingling |
Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial mo...
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Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial movement Last approximately 1hr 1/2 then full function returned
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| 42 | 2021-01-23 | vision blurred |
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ...
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Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
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| 42 | 2021-01-24 | eye twitching |
I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. ...
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I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.
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| 42 | 2021-01-24 | taste impairment |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | pain in jaw, ear pain, eye swelling, toothache |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-25 | tongue disorder, mouth tingling |
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig...
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1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
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| 42 | 2021-01-25 | eye pain |
2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, n...
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2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve
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| 42 | 2021-01-25 | dry eye |
Exceptionally dry eyes; This is a spontaneous report received from a contactable other healthcare pr...
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Exceptionally dry eyes; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown), via an unspecified route of administration in the left arm, on 12Jan2021 08:30, at single dose, for COVID-19 immunization, in the hospital. There were not medical history and concomitant medications. The patient has no known allergies and is not pregnant. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient experienced exceptionally dry eyes on 12Jan2021 at 20:30. Treatment included saline eye drops. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovered in Jan2021.
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| 42 | 2021-01-25 | ear pain, pain in jaw |
Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going ...
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Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248), via an unspecified route of administration in left arm on 08Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included migraines, anxiety, arthritis, EOE, IBS, asthma, possible autoimmune disorder AS, and known allergies with caffeine. Concomitant medications included topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL), montelukast sodium (SINGULAIR), and multivitamin. The patient previously took scopolamine allergies. The patient experienced headache on the left side, left sided ear, jaw and neck pain going on 4 days, extreme fatigue going on 4 days, since 08Jan2021 22:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has no COVID prior vaccination, has not been tested for COVID post vaccination. Treatment for the events included MEDROL dose pack and TYLENOL. The outcome of the events was unknown.
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| 42 | 2021-01-25 | loss of taste | that evening HA, myalgia, arthralgia, cough, stuffiness, sore throat, loss of taste on sun |
| 42 | 2021-01-26 | mouth numbness |
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo...
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Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
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| 42 | 2021-01-27 | taste impairment |
Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the morni...
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Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.
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| 42 | 2021-01-28 | taste disorder |
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given...
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c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
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| 42 | 2021-01-29 | visual impairment |
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha...
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45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
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| 42 | 2021-01-31 | loss of taste, loss of smell, thirst |
Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and t...
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Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and tastes
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| 42 | 2021-01-31 | taste disorder |
Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp...
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Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp pain in collar bone around during the 15 min waiting period of after injection.
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| 42 | 2021-02-01 | ear pain |
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache,...
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13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.
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| 42 | 2021-02-01 | ear discomfort, smell distorsion, taste disorder |
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse...
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I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
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| 42 | 2021-02-02 | deafness unilateral |
She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in lef...
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She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in left ear. She first noticed the loss of hearing occurred after a run. The pt had a piercing headache and the next morning she could not hear out of left ear. She recalls having a slight headache and tingling on the left side of her face, just after the vaccine. MRI of the brain normal. Prednisone taper, starting at 60 mg and received intratympanic steroid injections. The steroid did not help her regain her hearing. She was then seen by doctor and underwent a dozen hyperbaric O2 therapy. Pt is beginning to get her hearing back in left ear.
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| 42 | 2021-02-03 | eye pain |
Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This i...
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Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This is a spontaneous report from a contactable other hcp. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: El3248), intramuscular, in the left arm, on 08Jan2021 16:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced "left eye ball/socket soreness when moving side to side, up and down" and sinus pressure left eye on 10Jan2021 10:00. the outcome of events was recovering. Therapeutic measure taken as a result events included Sufdafed. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 42 | 2021-02-04 | eye pain |
Report chills, HA, eye pain and muscle pain (leg). Treatment: none, Outcomes: continues to work, do...
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Report chills, HA, eye pain and muscle pain (leg). Treatment: none, Outcomes: continues to work, does not interfere with ADLs.
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| 42 | 2021-02-04 | loss of smell, loss of taste |
Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. V...
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Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. Vaccine 2: Nausea, diarrhea, fatigue, severe body and muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.
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| 42 | 2021-02-05 | mouth tingling | TINGLING ON UPPER LIP FEW MINUTES AFTER VACCINATION |
| 42 | 2021-02-06 | mouth discomfort |
Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes...
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Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.
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| 42 | 2021-02-07 | ear pain, ear swelling |
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ...
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12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
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| 42 | 2021-02-07 | swollen tongue |
Client reports that she was feeling weird and was not a panic attack as she has had them before. Sh...
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Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.
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| 42 | 2021-02-07 | loss of taste, loss of smell |
Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of s...
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Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of smell and taste through Nov 24, 2020, since then I have had full taste and smell. About 6 hours after my 2nd shot things began to taste like cigarette ash, but my smell was fine. Then that evening things returned to normal. The next morning through about 1pm I was fine, things began a bit off around 1pm. By 4pm my taste and smell was gone on Sunday. Monday I have some smell and taste but it comes and goes. For instance I could taste the arugula in my salad but not the tomato. I could not taste a tangelo, but could taste a blood orange, eaten one right after the other. I now have most smell back as of 2pm Monday, but taste is intermitten.
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| 42 | 2021-02-07 | loss of taste |
Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 4...
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Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 22Jan2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported; however, it was reported that the patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 09:00, the patient experienced loss of taste. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of loss of taste was resolving. Information on the lot/batch number has been requested.
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| 42 | 2021-02-08 | mouth tingling | Red, itchy face with mild burning feeling, swollen throat with itch, and tingling in tongue. |
| 42 | 2021-02-09 | lip swelling |
I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, p...
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I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, pre-ventricular contractions. I had work up done. I had to get an IV of magnesium. I still have those symptoms intermittently and I am being followed up with my cardiologist.
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| 42 | 2021-02-10 | swelling of eyelid |
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She to...
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Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.
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| 42 | 2021-02-11 | feeling of choking, swollen tongue | Pt described a swollen tongue, racing heart, tingling throat. |
| 42 | 2021-02-14 | swollen tongue, mouth swelling |
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all...
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woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-15 | visual impairment |
I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vom...
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I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.
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| 42 | 2021-02-17 | smell distorsion |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-18 | extreme sound sensitivity |
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just...
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About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
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| 42 | 2021-02-18 | swollen tongue, taste impairment, mouth tingling |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | eye itchiness |
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February...
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Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. Â At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. Â She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. Â Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. Â She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. Â No known history of allergy to polyethylene glycol. Â No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. Â She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. Â She denies any recent medication changes or new over-the-counter medications. Â She has not previously been diagnosed with COVID-19.
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| 42 | 2021-02-22 | feeling of choking, mouth tingling |
Client reported "tingling in back of tongue and throat." Sensation lasted 15-20 minutes. Resolved ...
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Client reported "tingling in back of tongue and throat." Sensation lasted 15-20 minutes. Resolved without medication intervention. Client reported, "Sensation is gone. I feel okay now."
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| 42 | 2021-02-22 | mouth tingling |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-23 | mouth tingling, taste impairment |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | pain in jaw |
Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only...
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Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.
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| 42 | 2021-02-25 | tongue itchiness |
Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self wi...
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Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self with 25ml of Atarax saw improvement after 10 minutes; left on own accord.
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| 42 | 2021-02-27 | bloodshot eyes |
Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives ...
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Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .
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| 42 | 2021-02-28 | eye disorder, swelling around the eyes |
sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been p...
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sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been petting put cat. skin around right eye slightly swollen. Realized the liquid was under clear part of eye. Looked like some bubbled coming from top of eye, so weird. Could feel the liquid moving in eye when moving head. Touched the eye, liquid spread around iris and pupil not going over it. Was so weird. No pain. Felt that it had to be a reaction to the shot. My body seems to be pretty sensitive. I have had cold sore a few times back to back due to stress. My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child. Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction. The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data. Blah blah blah. I disagreed and left it at that. Had a benedylt last night and put a pataday drop in eye as recommended by PA
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| 42 | 2021-03-02 | ringing in ears | Ear crackling noise |
| 42 | 2021-03-02 | mouth tingling |
Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-ol...
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Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3246), via an unspecified route of administration (at the age of 42-years-old) on 21Jan2021 10:00 at a single dose in right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included rosuvastatin calcium (CRESTOR), spironolactone, tacrolimus, and macrogol 3350 (MIRALAX). The patient experienced lip tingling/fizzing on 28Jan2021 19:00 with outcome of recovering. No treatment received for the adverse event. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was considered as non-serious.
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| 42 | 2021-03-02 | ringing in ears | ear crackling noises |
| 42 | 2021-03-03 | thirst |
3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low gra...
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3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.
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| 42 | 2021-03-04 | eye itchiness, ear swelling |
42 yr old female patient complaining of sensation of (L) inner ear swelling as with food and mold a...
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42 yr old female patient complaining of sensation of (L) inner ear swelling as with food and mold allergens. Area below (L) eye slightly itchy. No redness or swelling noted of ear or eye.
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| 42 | 2021-03-05 | swelling around the eyes |
About two days after my vaccine, the area under my eyes significantly puffed up. About 6 months ago...
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About two days after my vaccine, the area under my eyes significantly puffed up. About 6 months ago I had cosmetic fillers put under my eyes and the vaccine caused a reaction
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| 42 | 2021-03-07 | taste impairment |
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel...
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10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
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| 42 | 2021-03-07 | lacrimation increased, eye pain |
Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nau...
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Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-08 | swelling around the eyes, eye swelling |
Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straig...
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Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straight hours now. No relief. Treating with calamine lotion and round the clock benedryl. No breathing issues.
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| 42 | 2021-03-09 | mouth numbness |
17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbon...
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17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbones down to my chin) and numbness in my fingertips.
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| 42 | 2021-03-09 | lip swelling |
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen li...
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Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
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| 42 | 2021-03-09 | sensitivity to light |
Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensi...
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Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
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| 42 | 2021-03-11 | visual impairment |
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f...
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Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
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| 42 | 2021-03-11 | mouth tingling |
Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of ...
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Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.
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| 42 | 2021-03-11 | vision blurred |
The logistician from station 3 alerted the observation area that a patient was not feeling well. Th...
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The logistician from station 3 alerted the observation area that a patient was not feeling well. The patient was sitting on the chair. She looked pale. She complained of feeling dizzy and lightheaded (went away 2 mins after getting the shot) and blurry vision (went away 5 seconds after getting the shot) Blood pressure: 118/76; Pulse 68. O2 sat unable to read d/t nail polish. Good capillary refill. She felt better after 20 minutes. She rested laying down with her feet elevated for 20 minutes. She sat down for 15 minutes and stood up for 5 minutes with no dizziness/lightheadedness. Patient texted that she arrived home safely and felt fine.
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| 42 | 2021-03-13 | visual impairment | Left side of my face doesn?t feel right. Almost numb and my vision to the left is off. |
| 42 | 2021-03-14 | mouth tingling |
10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies ...
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10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies difficulty breathing or throat closing. Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm
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| 42 | 2021-03-14 | ear discomfort |
3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATE...
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3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATES SHE IS 'OK AND READY TO GO HOME'. NO ACUTE OR OBVIOUS DISTRESS. A/O X3, PINK, W/D, RESP REG WITH EASE. NO CHANGE IN RASH AT THIS TIME. AMBULATORY, GAIT BRISK AND STEADY. 3-15-21 9:30AM TC: STATES 'RASH IS GONE, EARS STILL FEEL RAW AND STILL TAKING ALLEGRA'. WILL CHECK WITH PCP R/T DOSE #2.
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| 42 | 2021-03-14 | pain in jaw |
Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontane...
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Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.
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| 42 | 2021-03-14 | lip swelling |
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injec...
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Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
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| 42 | 2021-03-15 | hearing loss |
15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ear...
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15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ears are swelling like I'm on a plane". Pt reports having history of "severe allergies" Vital Signs: BP 162/75, HR 122, SPO2 99%. Reassessment 15:52 Vital Signs\ BP 138/84, HR 100, SPO2 99% Nurse alert alarmed, Pt transported via wheelchair
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| 42 | 2021-03-15 | lacrimation increased |
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND...
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WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
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| 42 | 2021-03-16 | loss of smell, loss of taste |
Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021. On 1/12/2021 developed loss of taste/smell,...
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Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021. On 1/12/2021 developed loss of taste/smell, rhinorrhea. Positive COVID test.
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| 42 | 2021-03-16 | vision blurred |
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f...
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Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
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| 42 | 2021-03-16 | taste impairment, taste disorder |
~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min....
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~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.
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| 42 | 2021-03-18 | loss of taste, thirst |
I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking st...
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I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking straight, can?t think in depth (it?s challenging to write graduate level papers); have to absolutely sleep 8-12 hours a night otherwise, I cannot function well with multi tasking as I did before the vaccine; Thirsty a lot more than usual, coughing sore throat (maybe this is normal w/the vaccine, I?m not sure). Today at 9:00pm, I realized that I lost my sense of taste. I ate a pizza and could not taste it. I am able to taste really sweet juice with my taste buds near the back of my tongue. This was something different today which is why I wanted to report. It does not feel like it is life threatening. Just uncomfortable to deal with. I?m so glad that I received the vaccine. If this is all that happens to me then , I am thankful for being alive and just having to deal with these discomforts while the vaccine is working through my system. Just note the symptoms maybe this is something in common with other people too.
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| 42 | 2021-03-19 | feeling of choking |
Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car an...
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Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen. I took liquid Benadryl 10ml at 3:55. The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued. On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.
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| 42 | 2021-03-21 | extreme sound sensitivity |
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ...
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lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-03-22 | vision blurred |
High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain,...
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High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain, dizziness and blurred vision.
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| 42 | 2021-03-22 | eye swelling |
Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated...
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Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.
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| 42 | 2021-03-22 | ringing in ears |
Ringing in the ears. I have seen Primary care doctor, ENT and acupuncturist. Ringing still persists....
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Ringing in the ears. I have seen Primary care doctor, ENT and acupuncturist. Ringing still persists. All doctors agree it will go away and is inflammatory response. It has NOT resolved as of today.
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| 42 | 2021-03-22 | taste disorder |
Terrible taste in my mouth with certain foods. Toothpaste, meat, veggie chips, coffee and other thin...
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Terrible taste in my mouth with certain foods. Toothpaste, meat, veggie chips, coffee and other things all taste like an ashtray smells.
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| 42 | 2021-03-23 | lip swelling, swollen tongue |
Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Be...
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Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Benadryl 50mg PO administered 1:50pm Epi pen given at 2:10pm
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| 42 | 2021-03-24 | swollen tongue |
Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and i...
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Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and itching in throat beginning approximately 20 minutes post vaccination. At this point patient notified observation nurse. Assessed by EMTs and nurse practitioner on site. Received injection of 25 mg of Benadryl. Began having relief of symptoms within 3 minutes. No Transported to hospital for observation. Received oxygen during transport. ER gave famotidine and loratadine via pills at 3:44 pm. Observation for approximately 70 minutes. At this point it had been approximately 4 hours since injection. BP and oxygen levels good. No itching. Released and returned home. Patient was cold and tired, which is typical for them when receiving a Benadryl injection. Slept for approximately 14 hours. Currently tired and achy, which is again typical for them after receiving a Benadryl injection.
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| 42 | 2021-03-24 | ringing in ears | Sudden onset of continuous ringing in right ear. |
| 42 | 2021-03-25 | ear pain |
Ear ache in left ear for several hours, tired, almost feverish feeling from late afternoon to evenin...
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Ear ache in left ear for several hours, tired, almost feverish feeling from late afternoon to evening the day of the vaccine and the late afternoon/evening the next day
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| 42 | 2021-03-25 | vision blurred |
I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath...
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I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.
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| 42 | 2021-03-25 | loss of smell, loss of taste |
Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + fo...
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Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + for and inconclusive for quest.
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| 42 | 2021-03-26 | swollen tongue |
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s...
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In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
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| 42 | 2021-03-26 | ear discomfort |
Numbness of the face as if I was coming out of dentist office. Still able to move my face but can no...
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Numbness of the face as if I was coming out of dentist office. Still able to move my face but can not feel my skin. Ears felt as if I was underwater or going in plane (trying to pressurize)
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| 42 | 2021-03-27 | ringing in ears, deafness unilateral |
Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, ti...
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Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, tinnitus reduced but has remained persistent for now well over a month. For last 3 weeks, experiencing intermittent extreme tinnitus in left ear followed by muffled hearing/hearing loss. Overall tinnitus volume now seems to be increasing/worsening.
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| 42 | 2021-03-29 | visual impairment |
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s...
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extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
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| 42 | 2021-03-30 | taste impairment |
Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not w...
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Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.
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| 42 | 2021-04-01 | vision blurred |
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?...
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Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
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| 42 | 2021-04-01 | eye bleeding |
blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old fe...
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blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 13:00 (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient is not pregnant. Medical history included a leiden factor a blood disorder. The patient had no known allergies. Concomitant medications included ibuprofen (MOTRIN); ashwagandha; ascorbic acid (VITAMIN C); and an unspecified Pfizer vaccine on 12Mar2021 administered in the left arm. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. On 11Mar2021 12:00 AM, the patient experienced blood in her eye. There was no treatment for the event. No COVID prior vaccination and was not tested with COVID post vaccination. The outcome of the event was recovering. Information about lot/batch number has been requested.
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| 42 | 2021-04-03 | thirst, ringing in ears, lip swelling |
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel...
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i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
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| 42 | 2021-04-17 | visual impairment |
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ...
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Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
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| 42 | 2021-04-18 | vision blurred |
Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get wo...
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Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-04-19 | ringing in ears, hearing loss |
My wife is unable to hear, she has a constant ringing, she has vertigo/dizziness, and nausea. We di...
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My wife is unable to hear, she has a constant ringing, she has vertigo/dizziness, and nausea. We discovered this after visiting an ENT on Monday, 4/19/21. He said that my wife developed a viral infection in both of her ears, possibly due to the vaccination she received a week earlier.
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| 42 | 2021-04-22 | ringing in ears |
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart p...
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Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
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| 42 | 2021-04-24 | deafness, ringing in ears |
Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a cont...
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Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history included blood clot from an unknown date. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No other vaccine in four weeks. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced cannot hear out of it at all and have tinnitus in her left ear on Mar2021 (reported as 02:30), 24 hours after the first dose. Took 2 weeks to return after the first dose. Outcome of cannot hear out of it all was recovered on an unspecified date while unknown for tinnitus.
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| 42 | 2021-04-24 | ringing in ears, deafness |
fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigu...
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fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigue; Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration in the left arm, on 06Apr2021 15:00, as single dose, for COVID-19 immunisation. Medical history included blood clot. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, therapy dates not reported. The patient did not have COVID-19 prior to vaccination and had not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) received at age 42 years, via an unspecified route of administration in the left arm, on 12Mar2021 16:45, for COVID-19 immunization, and within 24 hours, the patient experienced tinnitus in left ear and cannot hear out of it at all which took two weeks to return after the first dose. The patient did not receive other vaccines in for weeks. On 06Apr2021, the patient received the second dose. On 07Apr2021 at 02:30, the patient had tinnitus in his left ear and could not hear out of it at all. On 07Apr2021 at 03:00, 12 hours after the injection, the patient had a fever of 101 along with headache, muscle soreness and stiffness, and extreme fatigue. No treatment was given for the events. The outcome of the events was not recovered.
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| 42 | 2021-04-26 | oropharyngeal discomfort |
Patient presented for second dose of Pfizer Covid Vaccine. Has history of anaphylaxis to red bee ve...
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Patient presented for second dose of Pfizer Covid Vaccine. Has history of anaphylaxis to red bee venom and experienced throat discomfort with first dose Covid Vaccination and received Diphenhydramine susp 25mg by mouth with improvement in her throat discomfort within 5 minutes of administration. Water proved. Patient physically examined by physician. Pulse Ox 99% at discharge home with husband who was driving. Patient was advised on appropriateness of repeat dosage of 25mg Diphenhydramine if need later in the evening.
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| 42 | 2021-04-26 | ringing in ears |
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we...
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Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
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| 42 | 2021-04-30 | dry eye |
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid...
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Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
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| 43 | 2020-12-31 | mouth tingling |
Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am...
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Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am and the patient was discharged to home.
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| 43 | 2021-01-03 | swollen tongue |
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje...
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Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
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| 43 | 2021-01-03 | lip swelling, swelling around the eyes |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-03 | pain in jaw, eye disorder, mouth numbness |
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha...
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Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
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| 43 | 2021-01-04 | dry mouth |
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo...
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About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | ear discomfort |
Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny no...
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Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-05 | taste impairment |
5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt ...
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5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.
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| 43 | 2021-01-05 | lip swelling, taste impairment, mouth tingling |
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet...
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Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
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| 43 | 2021-01-05 | sensitivity to light |
extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue ...
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extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.
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| 43 | 2021-01-06 | mouth tingling |
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil...
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First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
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| 43 | 2021-01-06 | mouth numbness, taste impairment | metallic taste, numbess tonque and left arm, no treatemnt at present |
| 43 | 2021-01-07 | mouth numbness, mouth tingling |
Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with va...
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Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.
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| 43 | 2021-01-07 | visual impairment |
Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.;...
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Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
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| 43 | 2021-01-07 | vision blurred |
Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal ...
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Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal topographies showed swelling in the cornea; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (left arm, dose number 1) on 01Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa antibiotics, hormonal migraines, and gluten intolerance from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC), and spironolactone from unspecified dates for unspecified indications taken within two weeks. No other vaccine was taken within four weeks. Patient has not COVID prior vaccination. Patient has not been tested for COVID post vaccination. The patient experienced temporary blurred vision in the right eye on 02Jan2021. Patient stated that she is an optometrist so she performed a variety of tests and determined she had corneal edema. Corneal topographies showed swelling in the cornea, increased her nearsightedness from -1.25 to -1.75. By the time she left work 7 hours later, her vision and corneal topographies returned back to normal. Treatment was not given for the events. Event outcome was recovered on 02Jan2021. The reporter assessed the event was non-serious.
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| 43 | 2021-01-08 | taste disorder | Generalized edema, shortness of breath, change in taste |
| 43 | 2021-01-09 | lip swelling, ear discomfort, eye swelling |
Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swol...
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Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.
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| 43 | 2021-01-09 | taste impairment |
Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg...
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Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.
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| 43 | 2021-01-09 | sensitivity to light | Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site |
| 43 | 2021-01-10 | dry mouth | Headache started then I developed dry mouth that turned to ulcers on tongue |
| 43 | 2021-01-10 | eye itchiness |
Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the fol...
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Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the following 2 days. The only thing I am allergic to is Neosporin, so I don't know if any of those ingredients are in the Pfizer vaccine.
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| 43 | 2021-01-10 | eye itchiness |
Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on ...
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Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on the day of vaccination, but it got worse the next 2 days. The only medication I am allergic to is Neosporin, so I don't know if the vaccine has components of this in it.
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| 43 | 2021-01-11 | eye swelling |
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07...
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1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
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| 43 | 2021-01-11 | mouth tingling |
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho...
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After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
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| 43 | 2021-01-11 | visual impairment, tunnel vision |
I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and sta...
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I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and started feeling woozy and seeing spots. By the time I got back into my house, I had tunnel vision and could not see directly in front of me. I went to lay down, but ran into a piece of furniture because I was so disoriented and hit my shin on it. I collapsed on my bed. I stayed there for few hours and then I was ok. I had severe, flu-like symptoms for most of the day - fever, chills, low energy, joint pain (specifically back and hip) - that waxed and waned. I finally felt almost back to normal approximately 50 hours after the injection.
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| 43 | 2021-01-11 | toothache |
I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the v...
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I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the vaccine the pain began increasing to the whole left side of my face and neck and increasing in intensity. I was unable to sleep 12/24 and 12/25 and ended up going to urgent care on 12/26. Despite not having sinus fullness/drainage they diagnosed it a sinus infection and gave me antibiotics. At the end of the 5 day course my symptoms had improved some but were not gone and I was still requiring frequent Tylenol for pain so the course of antibiotics were extended. I do not know if this was caused by the vaccine, but it coincided with the vaccine.
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| 43 | 2021-01-11 | mouth tingling, lip swelling |
Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and...
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Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip. Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72. She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink. She was observed for 30 minutes and symptoms gradually improved. Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61. She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication. She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist. She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed. She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours. She expressed understanding. She stated that she was comfortable going home and continuing to monitor her symptoms.
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| 43 | 2021-01-11 | eye pain, loss of smell, loss of taste |
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ...
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lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 43 | 2021-01-12 | ear pain | Fever up to 102.9 Chills Nausea and vomiting Earache Headache Backache For |
| 43 | 2021-01-12 | loss of smell |
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w...
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I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
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| 43 | 2021-01-12 | eye discomfort, eye swelling |
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9...
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I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
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| 43 | 2021-01-12 | eye pain |
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ...
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Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
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| 43 | 2021-01-13 | mouth itchiness, mouth tingling, tongue itchiness |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | eye disorder |
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ...
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She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
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| 43 | 2021-01-13 | taste impairment |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | mouth tingling | reported uriticaria and lip/tongue tingling. po benadryl administered. |
| 43 | 2021-01-14 | mouth tingling |
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ...
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15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
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| 43 | 2021-01-14 | mouth tingling |
Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. ...
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Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. Pt. also c/o "tongue tingling." Blood pressure: 192/96, Heart Rate: 78, O2 sats: 97% on room air. Assessed by APN. No Epinephrine or Benadryl given at POD. EMS took patient via ambulance to be evaluated at Medical Center.
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| 43 | 2021-01-14 | swelling around the eyes |
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does...
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HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
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| 43 | 2021-01-14 | taste impairment |
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio...
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Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-14 | sensitivity to light |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-16 | lip swelling, mouth tingling, swollen tongue, thirst |
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l...
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I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
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| 43 | 2021-01-17 | mouth tingling |
Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy thr...
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Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy throat, face itching, tongue tingling. This was the individual's second dose, she had no issues with the first dose. She has history of allergy to IV contrast dye, but no previous issues with vaccines. Provided 50 mg Benadryl onsite and had no further issues, monitored for over one hour, symptoms improved, and drove herself home from vaccination event.
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| 43 | 2021-01-17 | vision blurred, ear discomfort, ear itchiness, eye pain |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-18 | eye swelling |
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts wo...
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Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
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| 43 | 2021-01-18 | loss of taste | Body ache, muscle pain, severe headache, fever(102.0) dizziness chill, loss of taste |
| 43 | 2021-01-18 | deafness unilateral |
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy...
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Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
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| 43 | 2021-01-18 | eye swelling | Rash on both arms and swelling in eyes |
| 43 | 2021-01-18 | swollen tongue |
Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pe...
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Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
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| 43 | 2021-01-19 | dry mouth |
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ...
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1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
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| 43 | 2021-01-19 | eye swelling |
24 hrs later of vaccination on 1/14/2021 my right eye got swollen until 1/16/2021 I went to the doct...
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24 hrs later of vaccination on 1/14/2021 my right eye got swollen until 1/16/2021 I went to the doctor on 1/15/2021 & I got steroid.
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| 43 | 2021-01-19 | eye swelling, bloodshot eyes |
Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14...
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Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14/2021, she noticed her right eye was swollen and red. Patient also complains of a headache. Patient took Benadryl and Ibuprofen without resolution of symptoms. Denied any problems with breathing or swallowing. Patient advised to see PCP or go to Urgent Care.
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| 43 | 2021-01-19 | visual impairment |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-21 | feeling of choking, mouth tingling |
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i...
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20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
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| 43 | 2021-01-21 | vision blurred |
Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later t...
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Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.
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| 43 | 2021-01-21 | taste impairment | Ran a fever for 24 hours, joint pain, metallic taste in mouth x 4 days and blisters on tongue. |
| 43 | 2021-01-21 | ringing in ears |
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal...
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Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
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| 43 | 2021-01-21 | mouth tingling, tongue discomfort |
Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy...
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Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy, I couldn't clear it, this was at 2:30. I was given a Claritin 10mg, 1 1/2 hrs later the sensation seemed to have cleared up. But 20mins later around 4:10pm my tongue started burning and tingling and within 15mins that sensation traveled to the back of my throat. Within 20mins from that I broke out in a rash on my chest, this was around 4:40. I was taken to ER and given 50mg Benadryl through the IV. My rash on my chest started going away but my throat and tongue still felt tingly and burning. It started barely clearing up around 8:45pm but it did not go away entirely, it is still here today 1/22/21 1:54pm, but not bothersome. It seems to be fading away as time goes. I will continue to take Benadryl at home every night until symptoms completely resolves.
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| 43 | 2021-01-22 | eye discomfort |
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in should...
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High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then motrin 2-3hrs later given, then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
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| 43 | 2021-01-24 | sensitivity to light |
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev...
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Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
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| 43 | 2021-01-24 | oropharyngeal discomfort, mouth tingling |
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b...
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Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
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| 43 | 2021-01-24 | ringing in ears |
Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extrem...
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Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extremely loud - more loud than ever before. I don't have any other lifestyle issues that would've aggravated the tinnitus.
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| 43 | 2021-01-25 | mouth numbness | NUMB TONGUE ON RIGHT SIDE FOR TWO DAYS; RESOLVED ON ITS OWN WITHOUT FURTHER INCIDENT |
| 43 | 2021-01-25 | mouth tingling |
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir...
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chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
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| 43 | 2021-01-26 | eye pain, ear pain |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | eye pain, ear pain |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | mouth numbness |
I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, howe...
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I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination. As of today, my symptoms remain, but seem to be improving.
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| 43 | 2021-01-26 | mouth itchiness |
Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchin...
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Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchiness progressed to various places mostly around her head and upper torso. She took 50 mg diphenhydramine about 10 minutes after first reporting the symptoms. She reported feeling fine about 1 hour later.
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| 43 | 2021-01-27 | taste impairment |
10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began...
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10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER
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| 43 | 2021-01-27 | ringing in ears |
Pfizer-BioNTech Covid-19 Vaccine . Ringing in Right ear and loss of hearing for approximately 5 hou...
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Pfizer-BioNTech Covid-19 Vaccine . Ringing in Right ear and loss of hearing for approximately 5 hours, fever, headache and pain on left arm where vaccine was inserted.
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| 43 | 2021-01-27 | tongue itchiness |
Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had...
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Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat and tongue.
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| 43 | 2021-01-27 | taste impairment |
constant metallic taste that started approximately 1 hour after receiving the vaccine that has now e...
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constant metallic taste that started approximately 1 hour after receiving the vaccine that has now exceeded 24 hours for duration.
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| 43 | 2021-01-27 | bloodshot eyes |
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ...
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intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
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| 43 | 2021-01-28 | oropharyngeal discomfort |
1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to ...
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1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to swallow". Oxygen saturation: 100% and HR: 85. 1:30 PM: Oxygen saturation : 98%, HR: 69 1:35 PM: Oxygen saturation: 98%, HR: 70. Reports feeling better. Sensation is improving. 1:40 PM: Oxygen saturation: 99%, HR 65, pt reports she feels okay 1:45 PM: Oxygen saturation: 98%, HR 67. 1:50 PM: Oxygen saturation: 98%, HR 70. Pt states she is ready to go and is feeling better. She had no difficulty talking or breathing.
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| 43 | 2021-01-28 | mouth tingling |
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report...
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Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
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| 43 | 2021-01-28 | taste impairment |
Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Ache...
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Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Aches, Fatigue all over starting 24 hours after receiving vaccine. Lasted for about 8 hours. Fully recovered by next morning.
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| 43 | 2021-01-28 | smell distorsion, taste disorder | taste/smell alteration within 1 hour of vaccine / facial twitching 3 days later / CNS depression |
| 43 | 2021-01-31 | sensitivity to light |
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t...
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01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
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| 43 | 2021-01-31 | inability to speak |
A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throa...
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A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throat, painful cough, chills. No fever. On 01/01 I woke up and had no voice. I went straight to the UC and they diagnosed me with upper respiratory infection, I was treated with azithromycin and something else for nausea. About days later I was totally fine.
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| 43 | 2021-02-01 | ear pain |
Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigemina...
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Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; This is a spontaneous report from a contactable Other Health Professional reporting for herself A 43 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at 12:15 at single dose intramuscular on arm left for COVID-19 immunization. Medical history included Trigeminal Neuralgia, asthma, High blood pressure, CSF leak out of my nose (which has spontaneously healed), Seasonal allergies, milk allergies to lactose, Allergy to arthropod sting (tongue swelled up once from a hornet sting on hand) and allergic reaction to antibiotics (hands swell up). Concomitant medications included propranolol. On 18Jan2021 soon after vaccination (reported as 18Jan2021 at 12:15), patient experienced backache and back spasms. Ear pain on right side of head. Patient had trigeminal Neuralgia and it made her face temporarily flare up with the side face pain (as reported). Patient didn't received treatment. At the time of the reporting the patient was recovering from the events. information on the lot/batch number has been requested.
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| 43 | 2021-02-01 | loss of smell |
Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsor...
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Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer (patient) reported that a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration in left arm on 07Jan2021 13:30 at single dose for covid-19 immunization (vaccination). Medical history included pleurisy. Family medical history was none. There were no concomitant medications. Historically she felt like she had the flu when she had gotten the flu vaccine (years not specified); but she did not feel like she had the flu after getting flu vaccine this year in 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient received the Pfizer COVID-19 vaccine 07Jan2021; and she tested positive for COVID-19 this week. Then clarified that she was administered first dose of Pfizer COVID-19 Vaccine 07Jan2021. She had onset of COVID-19 around 15Jan2021 when she became unable to smell. She had 2 COVID-19 tests performed on 16Jan2021, one was a rapid COVID-19 nasal swab test with positive result; the other was a COVID-19 nasal swab test that they had to send off to test which was also positive. No medications were taken prior to vaccination/event. She asked if she should still get the second dose as scheduled relative to this event. Second dose was scheduled for 27Jan2021. No emergency room visit required, physician office visit (urgent care) required for event COVID-19. She mentioned she was not the only patient to test positive for COVID-19 that received Pfizer COVID-19 Vaccine same date she received Pfizer COVID-19 Vaccine on 07Jan2021. She declined to provide any further information regarding those patients/events/products/report. The sample of product was not available to return. The outcome of events was unknown.
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| 43 | 2021-02-02 | dry mouth | Hives, Rash, itching, chest tightness, throat tightness, dry mouth, difficulty breathing |
| 43 | 2021-02-02 | gaze palsy |
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness...
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Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
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| 43 | 2021-02-02 | mouth numbness |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-03 | eye itchiness |
Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of he...
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Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of head, forehead, and eye; Cluster headaches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1686) via an unspecified route of administration in the left arm on 08Jan2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included migraines. Concomitant medications included magnesium, vitamin B12 and vitamins NOS (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin sulfate/polymyxin b sulfate (NEOSPORIN) and experienced allergy. On 08Jan2021 at 20:00, the patient experienced allergic reaction, itchiness on right side of head, forehead, and eye and cluster headaches. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and sumatriptan. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.
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| 43 | 2021-02-03 | taste impairment |
METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNI...
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METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNING 1/30/2021 GENERAL MALAISE 2/2-2/3/2021; TEMP ON THESE DAYS 99.4 DEGREES AND 99.7 DEGREES RESPECTIVELY I TOOK ACETAMINOPHEN ON 2/2/2021 BENADRYL 2/4/2021 - ITCHINESS SUBSIDED POST (1) DOSE TONGUE RASH PERSISTS AT THIS TIME
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| 43 | 2021-02-03 | tongue itchiness, taste impairment |
METALLIC TASTE IN MOUTH, RASH ON LATERAL ASPECTS OF BOTH SIDES OF TONGUE TOWARD APEX AND ITCHY TO...
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METALLIC TASTE IN MOUTH, RASH ON LATERAL ASPECTS OF BOTH SIDES OF TONGUE TOWARD APEX AND ITCHY TONGUE. GENERAL MALAIASE 2/2/2021 AND 2/3/21. TEMP TAKEN ON BOTH DAYS WITH READINGS BETWEEN 99.4-99.7 DEGREES. TOOK ACETAMINOPHEN 2/2/21 AND BENADRYL ON 2/4/21. TONGUE ITCH SUBSIDED POST 1 DOSE (2 CAPS) OF BENADRYL. RASH PERSISTS AT THE TIME OF THIS WRITING.
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| 43 | 2021-02-03 | ringing in ears |
Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringi...
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Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.
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| 43 | 2021-02-03 | lip swelling, taste impairment |
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd...
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Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
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| 43 | 2021-02-03 | loss of taste, loss of smell |
Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102...
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Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102.1 - had temperature all weekend and tried to bring it down with Tylenol. Went to work on Monday, Jan. 4, and was sent right home after taking a COVID test (result was negative). Follow up with my Doctor on Thursday, the 7th, and had another COVID test was a positive result. Friday, the 8th, my family went to clinic to test and so I tested again that day and my result was negative for that test. My symptoms were body aches, headaches, lost sense of taste and smell and fatigue. These lasted 5-6 days.
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| 43 | 2021-02-04 | gaze palsy |
Fever (100.3), joint and muscle pain and HA. Treatment: Tylenol with moderate improvement . Outcome...
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Fever (100.3), joint and muscle pain and HA. Treatment: Tylenol with moderate improvement . Outcome: Does not interfere with ADLs.
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| 43 | 2021-02-05 | taste impairment |
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit...
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Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
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| 43 | 2021-02-06 | swollen tongue, mouth numbness |
Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt lik...
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Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt like her tongue was numb / swelling
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| 43 | 2021-02-08 | ear discomfort, ringing in ears |
I developed tinnitus and a fullness in my left ear one week after receiving my first dose of the COV...
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I developed tinnitus and a fullness in my left ear one week after receiving my first dose of the COVID vaccine. The symptoms have remained persistent and consistent. All day I have tinnitus and a fullness in my left ear which has not subdued since the symptoms first started one week after receiving the COVID vaccine.
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| 43 | 2021-02-09 | vision blurred |
Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist....
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Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
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| 43 | 2021-02-09 | mouth tingling | Lip tingling, throat tight, cough, flushing, jittery sensation |
| 43 | 2021-02-09 | mouth numbness |
Patient complained of numbness around mouth post vaccine. Oral diphenhydramine 25 mg x 1 dose was a...
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Patient complained of numbness around mouth post vaccine. Oral diphenhydramine 25 mg x 1 dose was administered and symptoms resolved
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| 43 | 2021-02-10 | mouth tingling |
Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat...
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Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours. She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.
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| 43 | 2021-02-10 | smell distorsion |
fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable he...
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fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable health professional reporting for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot#EJ1686 via intramuscular route at the left arm on 20Jan2021 01:00 PM at single dose for COVID-19 immunization. Medical history included Hypothyroidism and allergy to codeine and sulfa. Concomitant medications were not reported. The patient had received the first dose of the same vaccine on 30Dec2020 01:00 PM from lot#EL1284, via intramuscular route at the left arm. On unknown date the patient experienced fatigue, chest congestion, chills and altered smell. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was diagnosed with COVID-19 on unknown date. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 26Jan2021 and the result was negative. The outcome of the events was not recovered.
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| 43 | 2021-02-14 | tongue discomfort, mouth tingling |
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne...
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Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-14 | swelling around the eyes |
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe...
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Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
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| 43 | 2021-02-15 | vision blurred | Facial flushing, asthma, blurred vision |
| 43 | 2021-02-16 | lip swelling, swollen tongue, swelling around the eyes |
My lips started swelling and my tongue swelled and throat got all itchy. My eyes were really puffy. ...
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My lips started swelling and my tongue swelled and throat got all itchy. My eyes were really puffy. I took Benadryl - I took 2. It made me sleep. I slept for about 1 hour and went back to sleep. I went back to sleep for 9 hours and the next day I I was a little tired and had some aches. Was fine after that.
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| 43 | 2021-02-16 | mouth tingling, swelling around the eyes, swollen tongue, lip swelling |
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu...
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pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
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| 43 | 2021-02-18 | tongue itchiness |
PATIENT COMPLAINS OF HEADACHE AND TONGUE ITCHING. PATIENT MONITORED AN ADDITIONAL 15 MINS. PATIENTS ...
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PATIENT COMPLAINS OF HEADACHE AND TONGUE ITCHING. PATIENT MONITORED AN ADDITIONAL 15 MINS. PATIENTS COMPLAINTS SUBSIDED.
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| 43 | 2021-02-19 | eye bleeding |
8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,...
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8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.
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| 43 | 2021-02-21 | smell distorsion | Parosmia foul smelling odors no one else smells that makes me very nauseous |
| 43 | 2021-02-22 | mouth itchiness |
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping....
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Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
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| 43 | 2021-02-22 | oropharyngeal discomfort |
Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throa...
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Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.
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| 43 | 2021-02-22 | lip swelling | Swelling of the lips- angioedema |
| 43 | 2021-02-22 | tongue itchiness |
Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening we...
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Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening went on, my neck became sore. I took an antihistamine that evening when I got home. The itchy tongue continued for approx 10 days, following the injection.
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| 43 | 2021-02-22 | lip itchiness, tongue itchiness, swollen tongue, lip swelling |
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; ...
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numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-22 | lip swelling, swollen tongue |
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt ...
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pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
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| 43 | 2021-02-23 | ear pain |
"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination...
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"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache
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| 43 | 2021-02-23 | dry mouth |
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ...
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Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
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| 43 | 2021-02-23 | eye swelling, swollen tongue, mouth swelling |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-24 | swollen tongue |
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc...
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A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
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| 43 | 2021-02-24 | oropharyngeal discomfort |
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik...
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About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
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| 43 | 2021-02-24 | vision blurred | Blurry vision, neck pain, patient refused to be seen by EMS. |
| 43 | 2021-02-24 | eye pain |
Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain....
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Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain. Muscle pain.
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| 43 | 2021-02-24 | taste impairment, lip swelling |
Right after injection, patient complaints of metallic taste and scratchy throat. 10 minutes after i...
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Right after injection, patient complaints of metallic taste and scratchy throat. 10 minutes after injection, patient developed mild swelling of lips. VS was stable, a dose of Benadryl 50 mg by mouth given. Patient was taken to ER.
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| 43 | 2021-02-26 | vision blurred, swelling around the eyes, eye itchiness, eye pain |
I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for ...
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I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for 30 mins, felt better. Next day skin itch got worse. Specially around my eyes.Eye itchy, rubbing, pain, vision blurry, puffiness, discharged, I bought some allergy drops but it didn?t get better. , on the 7 days after the vaccine, it was a Saturday, it got so much worse that I could barely open up my eyes. So I went to a clinic. The nurse practitioner gave me eyes drop for infection, it did not get better. She prescribed another eye drop, still not working. Now my eyes feel horrible,.
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| 43 | 2021-02-27 | mouth itchiness |
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built ...
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New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot. About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
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| 43 | 2021-02-27 | ear pain, pain in jaw |
Substantial pain in jaw on my right side. Pain radiates to ear. Hurts to open my mouth and chew. My ...
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Substantial pain in jaw on my right side. Pain radiates to ear. Hurts to open my mouth and chew. My jaw was clicking yesterday. Pain is way worse today Vs yesterday. I?ve never had this hurt so bad.
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| 43 | 2021-02-28 | eye pain, dry eye, eye swelling |
On 2/28 around 6pm. I started feeling some flu like symptoms start. Mild headache, fatigue, chills, ...
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On 2/28 around 6pm. I started feeling some flu like symptoms start. Mild headache, fatigue, chills, slight runny nose, mild sore throat. My left eye suddenly felt awful. I told my husband my eye is stuck (open). It was very scary and I felt like I had to hold my hand against it tightly. Meanwhile my right eye just wanted to stay closed, so then I couldn?t see at all. My husband guided me into the kitchen and I tried to flush my eye with water to see if that would help whatever was going on with my eye lid. My husband gently rubbed the skin above my eye. He couldn?t see my eye lid at all. All that was visible to him was the tip of my eyelashes. He was able to grab the tip of my eyelash and release my eyelid. It was very uncomfortable and scary. After the eyelid was released the eye was very sore . I called the nurse line and they recommended I be seen within 24 hours. I saw the doctor this morning not related at all to the vaccination facility. She said it sounded like an ocular muscle spasm. She said she didn?t see anything in the vaccine literature about this type of response but recommended I report it in case it?s a rare response. I have never had that happen before and I hope to never have it happen again.
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| 43 | 2021-02-28 | eye itchiness |
Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. R...
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Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. Resolution of symptoms before leaving vaccine site
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| 43 | 2021-03-01 | vision blurred |
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E...
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Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
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| 43 | 2021-03-01 | vision blurred |
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep...
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heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
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| 43 | 2021-03-02 | lacrimation increased |
Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on...
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Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on face, back , arms and left leg. patient says the itching was mild to moderate. No visible rash. Patient compared the itching to what happened after she took codeine. Then throat started itching, no shortness of breath or difficulty breathing. Eye also started watering. At midnight the patient took a Benadryl and this help relieve the itching. all the patient noticed was the injection site pain. Today she is still itching, but it is mild and did not warrant Benadryl. Advised patient if she experiences any form of shortness of breath to go to the emergency room.
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| 43 | 2021-03-02 | loss of taste, loss of smell |
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy...
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Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
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| 43 | 2021-03-02 | dry mouth, eye swelling |
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci...
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Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-03-03 | mouth tingling |
Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up with...
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Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up within 30 minutes, Have never had hives before. Some weird tongue sensation is lingering as well that has been lingering. Emailed Dr who said to avoid taking benedryl or steriods after second dose but it was ok to proceed with second dose.
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| 43 | 2021-03-03 | loss of taste, loss of smell |
Patient developed rhinorrhea and loss of taste/smell. She had a positive PCR for COVID-19 on 3/1/2...
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Patient developed rhinorrhea and loss of taste/smell. She had a positive PCR for COVID-19 on 3/1/2021. Received Pfizer vaccine on 1/20/2021 (lot EL3248) and 12/30/2020 (lot EL0142).
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| 43 | 2021-03-03 | dry mouth, dry throat |
This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm...
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This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm. Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms. Nurse came over and gave her epi pen at 1515 and sent to ER. In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F. Lungs CTA in ER. Headache worsened, but no difficulty breathin
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| 43 | 2021-03-05 | loss of taste, sensitivity to light, mouth tingling, pain in jaw, lacrimation increased, extreme sound sensitivity |
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to...
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5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck. 10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
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| 43 | 2021-03-06 | ear pain |
2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next t...
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2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next to it painful, itchy, hurts when push on toenails, awoken from sleep needing Tylenol Both got better without medical treatment.
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| 43 | 2021-03-08 | mouth tingling |
About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strang...
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About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strange swelling feeling around the backsides of my tongue, like the numbing feeling after a dentist visit. Then about 15 or 20 minutes later someone noticed a red slightly bumpy rash on my chest below my neck. It did not progress. I took Benadryl about 40 minutes after my shot and the rash and tongue feeling went away. I took Benadryl again 6 hours later . After that I had a mild headache and fatigue for two days. With some occasional nausea that would come and go for three days.
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| 43 | 2021-03-08 | loss of taste | Loss of taste |
| 43 | 2021-03-09 | swollen tongue |
16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 7...
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16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 75 02 99% RA, 17:27 pt staes tongue starting to swell, 17:32 epi 1:1000 .5ml IM left thigh 17:39: tongue improving 02 sat 99% RA 17:58 pt stable for discharge home, provided transport to car pt
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| 43 | 2021-03-09 | mouth numbness |
Numbness in lips and tongue, lightheaded and headache after 15 mins of getting vaccine. Fluids given...
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Numbness in lips and tongue, lightheaded and headache after 15 mins of getting vaccine. Fluids given at 1030am
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| 43 | 2021-03-09 | mouth tingling |
Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensatio...
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Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensation of tingling on the left side of her face and tongue. No other symptoms. Vaccine clinic was closed for the day, encouraged to seek care at an acute care. Confirms understanding.
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| 43 | 2021-03-09 | swelling of eyelid |
eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a s...
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eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a spontaneous report from a contactable consumer reporting for herself. A 43-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EM9810) vaccine , via an unspecified route of administration in the left arm on 05Feb2021 14:45 at single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included doxycycline (DOXYCYCLINE), loratadine, pseudoephedrine sulfate (CLARITIN-D). The patient experienced pain in left eyelid that felt like a bruise about 24 hours after shot on 06Feb2021 15:00 with outcome of recovering , eye lid swelling on 07Feb2021 02:45 with outcome of recovering. Both the events were considered non serious. The patient received Cold compress and Benadryl on advise from on call to treat the events. Follow up information has been requested.
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| 43 | 2021-03-10 | mouth numbness |
After receiving the pfizer covid vaccine pt c/o having an itchy throat and c/o dizziness. Pt was pl...
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After receiving the pfizer covid vaccine pt c/o having an itchy throat and c/o dizziness. Pt was placed supine on cot and vs obtained. VSS on RA. Color pink throughout. Pt continued to c/o itchy throat and then stated her lips where becoming numb. Epi 0.3 mg given via auto-injector per protocol. Ambulance called. Arrived within 6 minutes and took pt to the hospital for further evaluation.
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| 43 | 2021-03-10 | loss of taste, loss of smell | Loss of taste and smell and felt congestion |
| 43 | 2021-03-12 | ear discomfort |
Patient complained of feeling a burning sensation in her throat and ears 30 minutes after receiving ...
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Patient complained of feeling a burning sensation in her throat and ears 30 minutes after receiving the vaccination. The burning sensation subsided within 10 minutes.
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| 43 | 2021-03-13 | eye swelling, lip swelling | Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue. |
| 43 | 2021-03-13 | feeling of choking, mouth numbness, mouth tingling | Numbness and tingling in throat and tongue. |
| 43 | 2021-03-13 | oropharyngeal discomfort, eye swelling |
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with...
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Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
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| 43 | 2021-03-13 | ringing in ears, deafness unilateral, ear discomfort | Tinnitus in right ear Partial hearing loss Feeling of fullness in right ear Fatigue |
| 43 | 2021-03-14 | mouth swelling, mouth itchiness |
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing...
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Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
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| 43 | 2021-03-15 | mouth tingling |
43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DE...
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43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DENIES OTHER C/O TO INCLUDE DIFFICULTYBREATHING, SWALLOWING, SPEAKING, DENIES SWELLING IN OR AROUND FACE/MOUTH, NAUSEA, OR OTHER C/O. PT INITIALLY WAS WILLING TO GO TO ER BUT HER SXSUBSIDED WHILE WAITING FOR AMBULANCE AND SHE DECIDED TO AMA AND FOLLOW UP ON HER OWN. FOUND ABOVE PT A/O X4, NO OBV DISTRESS, NO OBVIOUS ANGIOEDEMA, SPEAKS IN FULL SENTENCES, CLEAR LS BILAT ALL, SOME HIVE LIKE RASH ON ANTERIOR CHESTBELOW THE CLAVICLES, EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE
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| 43 | 2021-03-15 | vision blurred |
Day 1 - Within 30 minutes of injection I felt dizzy and my vision was unfocused (almost blurry). D...
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Day 1 - Within 30 minutes of injection I felt dizzy and my vision was unfocused (almost blurry). Day 2 - The ocular disturbances continued and I had a huge headache. Almost felt as if my eyes were dilated. Day 3 - The back of my head and neck ached like whiplash from a car crash if I moved my head up and down; head felt stiff and heavy; ocular disturbances continue Day 4 - Same symptoms as Day 3 continue
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| 43 | 2021-03-15 | ringing in ears | My ears have been ringing since receiving the shot. |
| 43 | 2021-03-15 | taste impairment |
Notes Expand AllCollapse All Patient: ...
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Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
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| 43 | 2021-03-16 | vision blurred |
Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and ...
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Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and vision was blurry"; nausea-began having dry heaves (had not eaten), CBG 123, HR bradycardic and erratic, developed pounding HA, EMT stated "throwing PVCs"; then went to ER in POV
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| 43 | 2021-03-16 | mouth numbness |
First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 ho...
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First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 hours- Severe brain fog, confusion, lack of concentration and mental dysfunction. Lack of clarity, rational thinking and precise understanding. Felt like an inability to talk, make sound decisions or focus. Also feelings of eyes bulging and short temporary numb bottom lip. Feelings of brain abnormality and being drugged. Hour to two after-Feelings of coming down from days of an extreme caffeine high with no sleep. Worried, is mildly putting my reaction to the vaccine reaction/side effects. It was terrifying. I thought, I may not return from the negative adverse effects I was having. Something was certainly not right. It is something, I?m not sure I can go through again. Especially, with the second shot being stronger than the first. I was incapable of doing anything!
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| 43 | 2021-03-18 | eye twitching |
My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, ...
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My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, nausea, body aches, and heaviness in my chest began around 4:30 pm. Eye spasms stopped after taking ibuprofen but began again 7 hours later.
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| 43 | 2021-03-18 | ringing in ears |
Ringing in my ears/head. A loud high pitched ring. Making me crazy. Started around March 10th. Is no...
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Ringing in my ears/head. A loud high pitched ring. Making me crazy. Started around March 10th. Is not getting better.
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| 43 | 2021-03-19 | dry mouth |
Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours af...
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Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours after vaccine received, lasted 24 hours
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| 43 | 2021-03-19 | ringing in ears | Sore arm, headaches, tinnitus |
| 43 | 2021-03-21 | mouth tingling | VR stat burning from arm through chest, tingling tongue |
| 43 | 2021-03-22 | taste impairment |
After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 m...
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After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 minutes passed out. For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye. After receiving my second doses, I felt extremely tired and within 3 hours of receiving got shooting pain on left side of my face. I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021. This pain has been constant since receiving the second dose on March 8.
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| 43 | 2021-03-22 | mouth tingling |
Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly r...
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Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly resolved after 2 hours, though still felt around 6pm
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| 43 | 2021-03-22 | taste disorder, mouth numbness |
pt stated she immediately had a taste inside her mouth. Her mouth became numb and she developed bum...
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pt stated she immediately had a taste inside her mouth. Her mouth became numb and she developed bumps like blisters on the inside of the mouth. Pt contacted PCP and was told to go the ER if she got any worse. So today 3/23/2021 she went to the Urgent Care. She was given a steroid shot and prescribed famotidine 20mg x 2 days for 7 days. Pt still has these symptoms but waiting for the injection to help. Pt will FU w/ PCP.
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| 43 | 2021-03-23 | ringing in ears |
18hrs of solid sleep commenced after approx 7hr or wakefulness following vaccination. Ive been diag...
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18hrs of solid sleep commenced after approx 7hr or wakefulness following vaccination. Ive been diagnosed with mild tinnitus for about a decade. I mostly ignore it. However, about 48hr after shot#1 the volume began increasing... somewhere between 5 and 6 days after it was an 11 out of 10 on volume... so loud I couldn't find words to answer the phone. It comes and goes in waves, I have moments of tolerable racket, and hours of piercing ringing. Caffeine has no apparent effect for me. I eat a healthy diet, and exercise a couple days per week. I know aspirin can make it worse, but Excedrin has been the only OTC that's ever cut headaches for me, in my life. Right now I waver between crushing head plain, and undecipherable ringing. Any constant hum like a fan or fluorescent lights is like nails on a chaulkboard to me. Today is day 7, after a short night, i woke up to crushing head pain, showered and went back to bed, the head pain (without Excedrine) has subsided, giving way to fierce high pitched ringing. My neck muscles are tired... i just realized Ive been holing the "shudder" pose, shoulders raised to my ears, like one does to protect from a sudden loud noise.
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| 43 | 2021-03-23 | feeling of choking, mouth tingling, lip swelling |
20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage ...
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20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.
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| 43 | 2021-03-23 | lip swelling, mouth tingling |
3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose...
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3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose appointment. Pt reported that she had a reaction w/ pfizer vaccine. Received Pfizer vaccine on 3/2/21. From review of available outside records, pt called PCP (outside provider) on 3/5/21 reporting itchiness, lip swelling, tongue felt enlarged but no trouble swallowing or SOB 2 days post-vaccine. Pt was advised to continue benadryl and if s/sxs worsen to go to ED. Per pt, they later developed SOB and went to outside ED where she received epi-pen and prescribed prednisone course. Pt followed up with PCP on 3/11/21 and pt report improvement in symptoms. Pt was advised by PCP not to get 2nd dose of pfizer.
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| 43 | 2021-03-23 | mouth tingling |
Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of...
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Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of left side of mouth.
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| 43 | 2021-03-24 | taste impairment |
I did not eat before my appointment, and had taken 325mg of aspirin before the vaccine due to my chr...
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I did not eat before my appointment, and had taken 325mg of aspirin before the vaccine due to my chronic chest pain (undiagnosed). My other meds were taken the night before. Approximately ten minutes after receiving the vaccine, I developed a metallic taste in my mouth. After being observed for 45 minutes, I left and got something to eat. After I ate the metallic taste lasted another hour before diminishing.
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| 43 | 2021-03-24 | mouth tingling |
Patient called clinic with complaints of possible reactions to the second dose of the vaccine today....
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Patient called clinic with complaints of possible reactions to the second dose of the vaccine today. States that after she was observed for 15 minutes following the second dose of the Pfizer vaccine, she went home and noticed some slight tongue tingling that lasted for a few minutes then went away. She had her second dose today at 0945. Denies any reactions after her first dose. States now she has bumps on her skin similar to a skin rash with some pruritus. Denies wheezing, dyspnea, SOB, lip/tongue swelling, throat tightness, dysphagia, chest pain, nausea, vomiting. States she did take Zyrtec 10 mg this morning which is normal for her as she has allergies. She was currently at work when calling. Advised Pt of the following for treatment: 1. Topical hydrocortisone 1% cream to affected areas for the itch. Cool compresses for swelling and the itch. 2. OTC Zyrtec-- advised her to take a second dose of 10 mg tonight when going to bed. Also advised her to take Benadryl 25 - 50 mg every 4-8 hours as needed, max 300mg daily. Can be sedating, do not take with driving or operating machinery. Decided it would probably be best for her to leave work and go home in case she gets sleepy. She denied needing a work note at this time. 3. Advised to call 911 if signs and symptoms worsen at any time. Advised Pt not to follow up at \center if having any red flag symptoms but rather go to the ED immediately. Red flag symptoms: SOB, wheezing, lip/tongue swelling, throat tightness, chest pain. Discussed reaction with collaborating physician who was also the clinical observer for the vaccines today. Also made clinic manager aware
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| 43 | 2021-03-25 | lip swelling, eye itchiness |
Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. L...
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Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. Lips and lower face are becoming more swollen. I have no access to Health insurance so I will take a shower and some Benadryl, my only attainable recourse at this time.
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| 43 | 2021-03-25 | swollen tongue |
Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue withi...
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Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue within 45 minutes
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| 43 | 2021-03-25 | taste impairment | Metallic taste in mouth |
| 43 | 2021-03-26 | thirst |
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with...
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Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
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| 43 | 2021-03-28 | mouth tingling, swollen tongue, lip swelling |
43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyro...
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43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyroid papillary carcinoma who is presenting to the ED with an allergic reaction. She received her COVID vaccination at 1700. At approximately 1715 she felt a lump in her throat. Shortly after she felt as if her tongue/lips were tingling/becoming swollen and then she developed nausea. No rash or abdominal pain. No dyspnea or chest pain. All symptoms are consistent with prior episodes of anaphylaxis. She has had anaphylaxis to vaccinations in the past but was advised by her allergist to get the COVID vaccine today. On arrival patient is quite anxious. Vital signs are stable. Her tongue is enlarged/mildly edematous, additionally appreciated mild lip/perioral swelling. There is no stridor or wheezing, no evidence of respiratory distress. Given examination findings, symptom description, findings concerning for anaphylaxis. As such, epinephrine promptly administered as well as solumedrol, famotidine, and benadryl. Shortly after the epinephrine she endorsed improvement in her swelling, though during benadryl administration she endorsed a sudden onset of subjective throat swelling/felt as if she could not breathe. Patient was reassessed, no change in initial examination findings, within a few minutes she felt her symptoms improve without intervention.A short while later she again felt as if her throat swelling was worsening, as such epinephrine dose re administered. Following a 2.5 hour period of observation she endorsed continued improvement in her allergic symptoms, requested discharge home though continued observation offered. A course of prednisone prescribed, patient already with epi pen. Patient discharged home.
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| 43 | 2021-03-30 | vision blurred |
back of head and neck hurts, felt like whiplash; back of head and neck hurts, felt like whiplash; He...
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back of head and neck hurts, felt like whiplash; back of head and neck hurts, felt like whiplash; Headache/ back of head and neck hurts/ walking too much and looking up/down and left/right causes headache; Dizziness; blurry vision; sensation of eyes wanting to cross; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 11Mar2021 13:00 (at 43 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included glaucoma, asthma, and allergies to topical iodine, penicillin, and latex, all from an unknown date and unknown if ongoing. The patient was not pregnant. Concomitant medications included brimonidine tartrate (ALPHAGAN), brinzolamide (AZOPT), latanoprost (XALATAN) and an unspecified Inhaler; therapy dates and indications were unknown for all. The patient took these medications within two weeks before the event onset. The patient did not receive other vaccination within 4 weeks prior to the BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that on day 1 (11Mar2021), the patient experienced dizziness, blurry vision, and sensation of eyes wanting to cross. On day 2 (12Mar2021), the patient experienced headache, blurry vision, and sensation of eyes wanting to cross. On day 3 (13Mar2021), patient experienced back of head and neck hurts, felt like whiplash; walking too much and looking up/down and left/right causes headache. On day 4, the symptoms from day 3 continued. No treatment was received in response to the events. The adverse events involved hospitalization. The outcome of the events was not recovered. Information on batch/lot number has been requested.
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| 43 | 2021-03-30 | mouth pain, ear pain |
swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report ...
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swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered. Information on the lot/batch number has been requested.
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| 43 | 2021-04-09 | eye bleeding |
eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; hea...
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eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. Information about batch/Lot number has been requested.
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| 43 | 2021-04-17 | taste impairment |
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; he...
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Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-04-18 | swollen tongue |
Swelling of tongue and throat. BP 209/115 (pulse 104). Given Epi-Pen, then sent to hospital. Was at ...
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Swelling of tongue and throat. BP 209/115 (pulse 104). Given Epi-Pen, then sent to hospital. Was at hospital for 1 day, and received IV Solumedrol, Pepcid, IV Benadryl.
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| 43 | 2021-04-20 | eye discomfort |
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to ...
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I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-04-21 | ringing in ears |
About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a coup...
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About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a couple hours. I was then just tired on and off with a sore arm. On day 3 I started feeling congested with pulsing in my right ear followed by ringing tinnitus which continues to this day. I have taken Tylenol and ibuprofen a couple times, which doesn?t help much. I am currently over the 7 day mark from first dose.
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| 43 | 2021-04-23 | mouth numbness, lip swelling |
Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left sid...
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Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3302), via an unspecified route of administration in left arm on 13Jan2021 10:00 as single dose and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En5318) via an unspecified route of administration in left arm on 04Feb2021 11:00 as single dose for COVID-19 immunization. Patient age was 43-years-old and was not pregnant at the time of vaccination. Vaccine was administered at the military facility. Patient medical history included sleep apnoea syndrome. The patients concomitant medication included melatonin taken for an unspecified indication, start and stop date were not reported. The patient experienced cheek swelling on left side of face with numbing of lip due to swelling with numbing of lip due to swelling on 25Jan2021. No other vaccine in four weeks. Emergency room/department or urgent care. No COVID prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.
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| 43 | 2021-04-24 | ringing in ears, deafness |
Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus an...
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Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 03Apr2021 10:30 (Batch/Lot Number: ED7533) as single dose for covid-19 immunisation. Medical history included AV block, colitis, optic neuritis, previous hearing loss in right ears and pre-existing tinnitus in right ears all from an unknown date and unknown if ongoing. Concomitant medications included montelukast; clarithromycin (CLARITIN) and bisacodyl (DULCOLAX); all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and vancomycin and experienced allergies. The patient experienced experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination on 03Apr2021 13:00. Contacting doctor, the patient was hesitant to receive second vaccination. No treatment was received for the events. The patient did not recover from the events.
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| 43 | 2021-05-04 | eye bleeding |
A blood vessel burst in my right eye; headache; tired; This is a spontaneous report from a contactab...
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A blood vessel burst in my right eye; headache; tired; This is a spontaneous report from a contactable nurse. A 43-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 08:15 (Batch/Lot Number: 20921163) as a single dose for COVID-19 immunisation Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had not received any other vaccinations within 4 weeks. Concomitant medication(s) included chlorthalidone (CHLORTHALIDONE) taken for blood pressure measurement, start and stop date were not reported. The patient reported that a blood vessel burst in her right eye on 10Apr2021 at 0600, she also reported a headache and was tired. The patient states that she got her first dose of the Pfizer COVID vaccine on Friday 9Apr2021. Patient states that the next day a blood vessel burst in the right eye. Patient states that at first she was thinking she didn't know what to think. Patient states that she didn't know what to do. Patient looked online to see how long the eye would take to heal. Patient states that the redness has gone away, the side part of patient's eye looked like something happened. Patient states that it was a lot when it happened. Patient states that the following morning on the 10Apr2021 she had a headache in the morning. Patient states that on or around 6:00 AM or 7:00 AM on 10Apr2021 she woke up with the headache and noticed the burst blood vessel. Patient states that the headache woke her up. Patient states that she took something for the headache but it still kind of lingered and patient felt kind of off all day long. Patient states that it lasted then kind of gradually went away and she didn't feel that way after a couple of days. Patient states that was the first vaccination and she is set to get the second vaccination on 30Apr2021. Patient states that with having that reaction of the blood vessel in the eye, she wants to get on with her life. Patient states that she wants the other portion of the vaccination but is nervous about getting it. The outcome of the events for tbe blood vessel burst in her right eye was recovering and the remaining events was recovered on 10Apr2021. The patient was not tested for COVID-19 before or after vaccination.
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| 44 | 2021-01-02 | swollen tongue | numb pockets on face, a little swelling of tongue and a little tired/flushed |
| 44 | 2021-01-03 | eye irritation |
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ...
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first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
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| 44 | 2021-01-04 | mouth numbness, mouth tingling, ear pain |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | mouth tingling, lip swelling | Tingling of top lip with mild swelling |
| 44 | 2021-01-04 | mouth tingling, feeling of choking, mouth numbness |
lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips...
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lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
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| 44 | 2021-01-04 | toothache, ear pain |
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te...
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pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
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| 44 | 2021-01-06 | taste impairment |
Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired a...
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Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired and having a "metallic taste" in her mouth. Pt reported very little fluid or food intake prior to the vaccine. Given Gatorade and crackers; monitored for 30 min. Symptoms resolved. Patient received 2nd dose of vaccine on 1/6/2021 and no adverse reactions were reported during the 30 minute monitoring period.
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| 44 | 2021-01-06 | taste impairment |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-06 | mouth tingling |
Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccin...
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Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.
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| 44 | 2021-01-07 | thirst |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | eye swelling |
I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose ...
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I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose 1/6/2021. Forty- eight hours after second dose I had moderate to severe under eye swelling at site of dermal fillers I received May 20,2020 requiring steroids and antihistamine. I also had severe myalgias and fever 12 -36 hours after my second dose.
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| 44 | 2021-01-07 | blindness in both eyes |
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning...
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I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
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| 44 | 2021-01-07 | mouth numbness | Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative: |
| 44 | 2021-01-07 | ear itchiness |
Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on ...
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Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on its own in 1 hour. Did not need to call physician.
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| 44 | 2021-01-07 | taste impairment, eye irritation |
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m...
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Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
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| 44 | 2021-01-07 | ear pain |
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5...
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Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
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| 44 | 2021-01-07 | loss of smell |
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv...
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slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
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| 44 | 2021-01-08 | mouth tingling, ear discomfort |
1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my l...
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1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.
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| 44 | 2021-01-08 | dry mouth |
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli...
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1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
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| 44 | 2021-01-09 | eye swelling |
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ...
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I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
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| 44 | 2021-01-10 | oropharyngeal discomfort | Dec 17th, my throat felt scratchy, 45 minutes later I was wheezing. |
| 44 | 2021-01-10 | feeling of choking |
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin...
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Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
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| 44 | 2021-01-10 | oropharyngeal discomfort |
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even ...
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about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
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| 44 | 2021-01-11 | taste disorder, eye itchiness |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | mouth numbness |
About one hour after receiving the vaccine, my tongue went numb for about 12 hours. I had taste and ...
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About one hour after receiving the vaccine, my tongue went numb for about 12 hours. I had taste and smell, but tongue was numb.
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| 44 | 2021-01-11 | taste disorder, eye itchiness |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | mouth numbness |
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult brea...
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Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
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| 44 | 2021-01-11 | swollen tongue |
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo...
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Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
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| 44 | 2021-01-12 | vision blurred |
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea...
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10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
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| 44 | 2021-01-12 | lip swelling |
@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also re...
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@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well. Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.
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| 44 | 2021-01-12 | eye pain |
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Ras...
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Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
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| 44 | 2021-01-12 | eye pain |
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/202...
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Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
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| 44 | 2021-01-13 | burning mouth syndrome |
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ...
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"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
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| 44 | 2021-01-13 | loss of smell |
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I ...
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Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
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| 44 | 2021-01-13 | burning mouth syndrome |
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme...
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Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
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| 44 | 2021-01-13 | ear pain |
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),...
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Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
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| 44 | 2021-01-13 | taste impairment |
Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any...
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Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any other s/s of distress. No SOB/Trouble breathing as well.
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| 44 | 2021-01-14 | swollen tongue |
After the administration of the COVID-19 vaccine, during the observation period, the patient showed ...
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After the administration of the COVID-19 vaccine, during the observation period, the patient showed a swollen tongue and shortness of breath
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| 44 | 2021-01-14 | bloodshot eyes, eye discomfort |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | dry mouth | Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia |
| 44 | 2021-01-16 | vision blurred |
1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, seve...
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1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, severe headache and blurry vision
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| 44 | 2021-01-17 | mouth tingling |
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ...
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Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
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| 44 | 2021-01-17 | ear discomfort |
My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevat...
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My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevations. The effects lasted for a little over an hour.
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| 44 | 2021-01-18 | oropharyngeal discomfort, feeling of choking |
The patient received the COVID-19 vaccine at approximately 10:00 and within 10 minutes stated that h...
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The patient received the COVID-19 vaccine at approximately 10:00 and within 10 minutes stated that her throat was tingling and scratchy and she felt like she had something in her throat. She proceeded to try to clear her throat. These symptoms worsened and the patient was sent to the ED for observation/treatment. Benadryl 25mg IVP, Pepcid 20mg IVP, Solu-Medrol 125mg IVP and Zofran 4mg IVP was administered at 10:54. Then a GI Cocktail was also administered PO (contains Donnatol, Lidocaine and Maalox) immediately following. Ativan 0.5mg IVP was administered at 11:28. The patient was discharged home at 12:27 and was stable. Take home prescription from the ED was for Prednisone 40mg daily for 5 days.
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| 44 | 2021-01-18 | eye pain | fever, joint pain, muscle pain, eye pain. called in sick to work. |
| 44 | 2021-01-19 | lip swelling |
Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team ...
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Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives). Patient was counseled by lead pharmacist regarding risk and and data related to vaccine. Patient agreed to receive vaccine. Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay. Patient was observed by nursing. At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech. She has administered 50mg Benadryl suspension. Vital signs taken: 1900: 147/92; 82; 97% room air 1905: 132/101; 84; 97% room air 1910: 145/104; 84; 97% room air. 1915: 147/104; 81; 97% room air RN observer called vaccine physician on call at 1915 regarding patient status. Patient was then observed to have hives around her neck, upper chest and arms. RN then called again at 1924. Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine. Pharmacist pulled up 0.3mL of epinephrine. Administered injection in right thigh at 1934. Ambulance called and arrived on site at 1936. Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
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| 44 | 2021-01-20 | loss of taste, loss of smell |
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C...
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near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-21 | mouth itchiness, eye itchiness |
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes...
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48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
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| 44 | 2021-01-21 | thirst, dry mouth |
Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting ...
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Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting until the next day. Resolved over time.
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| 44 | 2021-01-21 | ringing in ears |
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my...
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I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
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| 44 | 2021-01-21 | eye swelling |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-24 | mouth tingling |
After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later pa...
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After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past
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| 44 | 2021-01-24 | toothache |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-24 | mouth tingling | Tingling around the mouth, throat swelling, and bronchospastic cough |
| 44 | 2021-01-24 | sensitivity to light |
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,...
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Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
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| 44 | 2021-01-25 | vision blurred |
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines...
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Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
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| 44 | 2021-01-25 | vision blurred |
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision....
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Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
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| 44 | 2021-01-25 | taste disorder |
Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "wei...
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Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "weird taste" in mouth. The symptoms began about 15 minutes ago after receiving the Pfizer COVID vaccine dose #1 Patient was treated with Benadryl, Solu-medrol and NS 1L bolus. Symptoms improved. Normal lung sounds. No signs of further reaction
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| 44 | 2021-01-26 | vision blurred |
Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limi...
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Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limits. O2 saturation normal. Started about 15 minutes after vaccination and lasted another 15 minutes. No medications or other interventions needed. Will follow up with their physician.
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| 44 | 2021-01-26 | mouth tingling, taste impairment |
Metallic Taste / Tingly lips. Observed for 30 minutes. Only reported symptoms at 15 minute mark in...
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Metallic Taste / Tingly lips. Observed for 30 minutes. Only reported symptoms at 15 minute mark in observation and reported improving. denies any symptoms of throat swelling. Released to home.
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| 44 | 2021-01-26 | ringing in ears |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | tongue itchiness |
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue...
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surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-27 | lip swelling |
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel...
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1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
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| 44 | 2021-01-27 | dry throat |
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ...
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40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
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| 44 | 2021-01-27 | lip swelling, swollen tongue | Edema in both hands and arms. Swollen face Lower lip swelling and tongue swelling |
| 44 | 2021-01-27 | feeling of choking | Lightheaded, dizziness, throat tingling |
| 44 | 2021-01-27 | inability to speak |
Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Sy...
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Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Symptoms lasted 2 days.
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| 44 | 2021-01-27 | eye irritation, eye swelling |
bilateral eye irritation; edematous right eyelid since day of 2nd vaccine; This is a spontaneous rep...
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bilateral eye irritation; edematous right eyelid since day of 2nd vaccine; This is a spontaneous report from a contactable nurse reported for herself. This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 12Jan2021 10:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), paracetamol (TYLENOL). Previously the patient received the first dose of BNT162B2, intramuscular in the left arm on 24Dec2020 02:00 PM for Covid-19 immunisation. On 12Jan2021 12:00 PM, the patient experienced bilateral eye irritation, edematous right eyelid since day of 2nd vaccine. No treatment was performed. The outcome of the events was not recovered. The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post the vaccination. Information on the lot/batch number has been requested.
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| 44 | 2021-01-27 | eye swelling |
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T...
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her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
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| 44 | 2021-01-28 | mouth tingling, mouth discomfort | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | thirst |
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi...
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My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
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| 44 | 2021-01-28 | swelling of eyelid |
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the thr...
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No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
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| 44 | 2021-01-28 | swelling of eyelid, eye pain |
Per Client on 1/27/2021 at 6:00 am awaken to left under eye lid swollen and tender. Per Client no me...
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Per Client on 1/27/2021 at 6:00 am awaken to left under eye lid swollen and tender. Per Client no medication taken for symptoms. Currently have not been seen by medical provided regarding symptoms. Per Client symptoms have not resolved and is planning to follow up with PCP today.
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| 44 | 2021-01-28 | ringing in ears |
This is a spontaneous report from a contactable physician. A 44-year-old female patient received sec...
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This is a spontaneous report from a contactable physician. A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant. There were no concomitant medications. The patient received first dose of BNT162B2 on 18Dec2020 08:00 AM at left arm lot number= EJ1685. On 09Jan2021 11:00, the patient experienced right tinnitus. The patient did not receive treatment for the event. The outcome of the event was not recovered.
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| 44 | 2021-01-28 | feeling of choking |
Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a m...
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Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140, expiry date: unknown), intramuscular on 23Dec2020 18:00 at single dose (left arm) for COVID-19 immunization. Medical history included hypertension and allergies to medications, food, or other products: Shellfish, phenergan, possibly sulfa. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin, amlodipine, fluticasone propionate (FLONASE); medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient, within 5-10 minutes injection, had tingling back of throat and increased mucus that lasted less than a minute on 23Dec2020 18:15. The outcome of the events was recovered on an unspecified date. Treatment was not received for the adverse event. Patient received second dose of bnt162b2 (lot number El3248) intramuscular on 14Jan2021 17:00 (vaccine location: Left arm). Events were reported as non-serious.
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| 44 | 2021-01-29 | loss of smell |
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid o...
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At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid on couch. Fell asleep, per family hallucinated. About 1 to 2 hours later I could not smell.
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| 44 | 2021-01-31 | vision blurred |
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca...
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10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
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| 44 | 2021-01-31 | eye pain |
Approximately three hours after injection the lymph node in the armpit closest became swollen and ar...
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Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
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| 44 | 2021-02-02 | sensitivity to light, extreme sound sensitivity |
Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened wit...
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Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened with 12-16 Motrin daily. Had injection of Toradol and started imitrex this morning after going to my doctor, but still no change.
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| 44 | 2021-02-03 | ear pain |
RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SY...
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RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SYMPTONS GOT WORSE NEXT DAY WITH INCREASED BODY ACHES,FEVER,SNEEZING, EAR PAIN,GLANDS SWOLLEN. TESTED FOR COVID 19 ON 01/26/2021. RESULTS WERE NEGATIVE AND WAS TOLD TO FOLLOW UP WITH PCP AND COULD NOT RETURN TO WORK TILL SYMPTONS IMPROVING. WENT TO PRIMARY DOCTOR AND WAS SWABBED FOR FLU,BACTERIAL.FUNGAL INFECTION. RESULTS CAME BACK AS BACTERIAL INFECTION AND AM NOW ON BACTRIM DS. STILL HAVING HEADACHE AND TIREDNESS.
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| 44 | 2021-02-03 | mouth tingling |
Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms...
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Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms in abdomen throughout the night; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3248, via an unspecified route of administration on 18Jan2021 at 10:15 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Fluoxetine hydrochloride (PROZAC), valaciclovir hydrochloride (VALTREX), Cetirizine hydrochloride (ZYRTEC ALLERGY) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took iodine and experienced drug allergy. On 18Jan2021 at 12:00, the patient experienced tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night. The patient did not receive any treatment for the events. The clinical outcomes of tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-02-04 | eye twitching, mouth tingling |
15 min after vaccine administered patient stated she had a frontal headache radiating to her right s...
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15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
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| 44 | 2021-02-06 | mouth tingling, mouth numbness |
About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on th...
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About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on the right side of my face. The sensation was located under my cheekbone and expanded to my jaw. It gradually spread to my chin and lips. It lasted for approximately four hours. When I woke up the next morning it was gone. The day after the vaccine I had more common side effects.
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| 44 | 2021-02-07 | lacrimation increased |
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w...
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Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
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| 44 | 2021-02-07 | loss of smell |
tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't...
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tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization. The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.
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| 44 | 2021-02-08 | feeling of choking |
On 2/9/21, The associate had a tingling sensation in her throat and forehand and it felt like her th...
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On 2/9/21, The associate had a tingling sensation in her throat and forehand and it felt like her throat was closing up. The associate stated to the nurse that she had the same issue with the first dose and she did not notify anyone of the that reaction. She just went home and took benadryl and it resolved. The associate received diphenhydramine (50 mg per ml IM once ) on 2/9/21 .
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| 44 | 2021-02-08 | swollen tongue, lip swelling |
Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was adminis...
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Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing
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| 44 | 2021-02-09 | swelling of eyelid |
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b...
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fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
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| 44 | 2021-02-10 | eye pain, ear pain |
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't k...
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Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night. Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning. Had televisit on 2/8/21 who advised me to be further checked out. At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey. Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days. They also advised to tape my eye shut when sleeping. My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
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| 44 | 2021-02-10 | lip swelling, swollen tongue, mouth tingling |
Within 5 minutes of receiving covid vaccine #1: Tingling lips, swollen tongue, swollen lips. All s...
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Within 5 minutes of receiving covid vaccine #1: Tingling lips, swollen tongue, swollen lips. All symptoms resolved in 1hour
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| 44 | 2021-02-11 | dry mouth |
PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH....
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PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH. PATIENT STATES SAME REACTION LIKE WHEN SHE HAS PEANUTS. PATIENT TOOK 25 MG OF HER BENADRYL AND STATES IS GOING TO MED CENTER NORTH FOR FURTHER TREATMENT. PATIENT DID NOT WANT ANY FURTHER TREATMENT FOR SYMPTOMS HERE AT THIS TIME.
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| 44 | 2021-02-11 | oropharyngeal discomfort |
Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN53...
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Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN5318. Patient has history of severe head to toe rash within minutes of receiving Vancomycin/Gent IV. Order obtained from APRN to give dose and monitor for 30 min. Patient alerted monitoring nurse at 10:59AM that she was experiencing a "scratchy" throat and difficulty swallowing. BP 130/88 O2 99% room air, P84. Epi 0.5mg 0.5ml (Lot 339384) administered LD IM at 11:02 AM. Patient hesitant with receiving Benadryl, does not respond well, has to take allegra instead; Benadryl not given. EMS arrived at 11:08AM and assumed care of patient. Patient transported to Hospital. Attempted phone call on 2/11/2021 with no answer.
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| 44 | 2021-02-11 | eye itchiness |
Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experien...
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Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experiencing bilateral itchy eyes. She went to urgent care and they gave her eye drops (unknown medication) but they made her sleepy so she discontinued. Patient presented to employee health and was recommended to take 10 days of oral anti-histamine without improvement. Re-presented to employee health 2/9/21 reports of increased eye itching and that itching was migrating down to her neck. She denied itchiness of the throat, rash, or redness. Employee health sent patient to urgent care.
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| 44 | 2021-02-14 | taste impairment, loss of taste, ear discomfort |
Within 45 minutes, had an overwhelming metallic taste in mouth. Lost ability to taste food for 36 h...
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Within 45 minutes, had an overwhelming metallic taste in mouth. Lost ability to taste food for 36 hours. Also had a fuzzy feeling in ears. Next day had fatigue, headache, aches, shortness of breath. Subsided within 48 hours.
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| 44 | 2021-02-15 | swollen tongue, burning mouth syndrome |
Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. ...
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Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.
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| 44 | 2021-02-18 | loss of smell, loss of taste |
Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach p...
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Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach pain Chills Fever Extreme swelling on left arm / injection site
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| 44 | 2021-02-21 | inability to speak |
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ...
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1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
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| 44 | 2021-02-21 | tongue discomfort |
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that...
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About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
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| 44 | 2021-02-21 | ear pain, loss of taste |
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai...
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Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
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| 44 | 2021-02-22 | deafness, loss of smell, loss of taste |
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th...
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Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 44 | 2021-02-22 | eye swelling, mouth swelling, lip swelling, swollen tongue |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
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| 44 | 2021-02-23 | oropharyngeal discomfort, taste impairment |
Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was...
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Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was checked by paramedics and cleared refused treatment.
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| 44 | 2021-02-24 | mouth tingling, mouth numbness | Initial symptoms numbeness and tingleness in mouth anf face; hour after vaccine both hands dark blue |
| 44 | 2021-02-25 | swollen tongue |
I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to ...
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I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 44 | 2021-02-26 | eye itchiness, visual impairment, eye discomfort |
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther...
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The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
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| 44 | 2021-02-27 | ear pain |
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ...
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Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
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| 44 | 2021-02-28 | ear pain |
01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching a...
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01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching along the mandibular branch of the facial nerve. This lasted ~ 4 hours 01.26.21: fever 99.2, nausea & dry heaving, left sided ear and throat pain, coughing, body aches, fatigue. These symptoms lasted ~ 12 hours
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| 44 | 2021-02-28 | mouth tingling |
1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hour...
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1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hours. 30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days. The following morning I also had flu like symptoms. Those lasted 24 hours.
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| 44 | 2021-02-28 | swollen tongue, mouth tingling |
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell....
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One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
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| 44 | 2021-02-28 | ringing in ears |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | tongue disorder, swollen tongue, eye pain |
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton...
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Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
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| 44 | 2021-02-28 | mouth tingling |
Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure,...
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Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure, blood sugar, and looked at my face and neck to see if she could see a reaction from the outside. These symptoms stopped 1 hr after vaccine. Then, very slight rash on neck and chest the next day (2/28) red spots (no itching), no treatment. Today (3/1) the rash is lighter and many spots are gone.
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| 44 | 2021-02-28 | eye pain |
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle...
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injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
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| 44 | 2021-03-01 | lip swelling, swollen tongue |
S: Adverse reaction following administration of COVID-19 vaccine B: Patient received COVID-19 vacc...
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S: Adverse reaction following administration of COVID-19 vaccine B: Patient received COVID-19 vaccine at 1630 and was monitored for 15 minutes post vaccination. A: Before leaving following appointment, patient reported that her throat "felt scratchy" and "didn't feel right." Patient denies shortness of breath and stated that her scratchy throat was her only symptom and stated that maybe it was not a big deal. She was given a cup of water and took a drink. She then stated that she felt it was getting worse. She stuck her tongue out and stated that she felt like it was swelling up. Her lips appeared to be swelling as well. R: At 1648, epi pen was administered to patients right thigh. Patient was transported to the ER via wheelchair. Call placed to ER and report was given. Patient was not seen in the ER, reason unknown.
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| 44 | 2021-03-01 | tongue discomfort, mouth tingling, taste impairment |
While eating lunch, tongue started burning and tingling with odd taste in mouth. The bitter taste, ...
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While eating lunch, tongue started burning and tingling with odd taste in mouth. The bitter taste, almost like soap, and the tingling sensation lasted until bedtime that evening. All ingedients in lunch have been tolerated before, had eaten from this same batch of vegetables and meat the day before with no issues. Per advisement of physician in my work office, i took 50mg Benadryl when i got home. Ate from the same batch of food 2 days later and no odd taste or tingling sensation.
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| 44 | 2021-03-02 | eye swelling |
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side...
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2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
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| 44 | 2021-03-02 | double vision |
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double v...
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Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
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| 44 | 2021-03-02 | loss of taste |
Tested for SARS COV-2 on 3/1/21 prior to travel, asymptomatic at the time of test. On 3/1/21, after ...
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Tested for SARS COV-2 on 3/1/21 prior to travel, asymptomatic at the time of test. On 3/1/21, after the test, she began having nasal congestion, body aches, achey at the base of her lungs and intermittent loss of taste. PCR test resulted evening of 3/1/21 was positive.
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| 44 | 2021-03-04 | mouth numbness, mouth tingling |
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l...
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Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
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| 44 | 2021-03-05 | oropharyngeal discomfort |
During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was...
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During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was feeling tight. RN requested on site MD to come over and evaluate. After several minutes of MD speaking with pt, pt stated she felt as if her chest tightening was getting worse and it was painful and that her throat was "feeling weird". MD stated to alert on site Medics and have them complete further evaluation. Medics completed their eval and had on site first responder request an ambulance to further evaluate pt. EMS arrived at 1028 and after completing their evaluation of pt, it was determined to take pt to the hospital for further evaluation. Pt significant other drove their personal vehicle home. Pt was transported via ambulance at 1045 in stable condition to the hospital.
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| 44 | 2021-03-06 | lip swelling, swelling of eyelid, mouth numbness | Fever, body aches, arm pain (at injection site); bilateral eyelid swelling, lip numbness/swelling |
| 44 | 2021-03-09 | eye itchiness |
Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report...
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Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report from a contactable other health professional (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, Right arm on 05Feb2021 at single dose for covid-19 immunisation (Age at vaccination 44 years) at hospital. Patient was not pregnant at the time of vaccination. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications received within 2 weeks of vaccination. Medical history included ehlers-danlos syndrome (EDS), mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS). Allergies to medications, food, or other products included Latex allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID 19, Pfizer, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration, Right arm on 15Jan2021 at single dose for covid-19 immunization (Age at vaccination 44 years). On 06Feb2021, the patient experienced body aches, chills, headache, itching eyes & body. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No treatment was received for the events. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-09 | swollen tongue, dry mouth |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-09 | feeling of choking | Tingling in throat, numbness of ankle and toes |
| 44 | 2021-03-10 | mouth tingling |
Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart ra...
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Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart racing" and complaints of tingling of the tongue. No shortness of breath or distress. Vitals were taken twice. ECG monitor was placed due to family cardiac issues. ECG was normal sinus rhythm.
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| 44 | 2021-03-10 | mouth tingling, lacrimation increased |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | mouth tingling |
Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site....
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Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site. Temperature 99.8
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| 44 | 2021-03-11 | swollen tongue | Swollen throat, swollen tongue. Swollen trachea. Respiratory difficulty |
| 44 | 2021-03-12 | deafness unilateral |
Acute hearing loss unilaterally (right ear) beginning D7 after dose 1, peaking at D10-13 after dose ...
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Acute hearing loss unilaterally (right ear) beginning D7 after dose 1, peaking at D10-13 after dose 1 with moderate recovery by D15. Again, acute hearing loss after second vaccine (R>L) beginning on D7, peaking on D11-16. Today is D16 with no recovery whatsoever.
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| 44 | 2021-03-12 | swollen tongue, tongue itchiness |
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen...
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Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
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| 44 | 2021-03-13 | lip swelling, dry mouth, thirst, swollen tongue, mouth swelling |
Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of ...
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Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of cotton. My lips swelled. This happened within a few minutes of getting the vaccine. I was already being observed in a 30 minute seat, 20-30 minutes were added and three different professionals addressed the issue including a nurse practitioner. About 20 minutes after leaving the facility, about 1.5-2 hours after getting the vaccine, I noticed I was easier to breathe and I hadn?t realized how much my tongue and inside of mouth had been swollen previously. After these 2 hours, I felt fine. The following day I experienced a headache and was tired. Otherwise was fine.
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| 44 | 2021-03-13 | mouth swelling |
Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated ...
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Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated with Benadryl
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| 44 | 2021-03-14 | mouth tingling |
PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100...
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PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100 AND REGULAR. PATIENT HAS NO SHORTNESS OF BREATH, NO RASH OR ITCHING. PATIENT WATCHED AND EXTRA 15 MINS BUT REFUSED TO GO FOR FURTHER TREATMENT.PATIENT INSTRUCTED TO FOLLOW UP WITH EMERGERGENY DEPARTMENT OR CLINIC IF HAD FURTHER NEDDS OR ISSUES DID NOT RESOLVE.
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| 44 | 2021-03-15 | dry throat, burning mouth syndrome, feeling of choking |
I felt like I was stung by something on the far back part of my tongue. I then felt like my throat a...
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I felt like I was stung by something on the far back part of my tongue. I then felt like my throat a dry, scratchy and tingled. This continued for several hours. I took benadryl at 230 and after 45 minutes it subsided a bit. Still there but not as strong. I also got a headache on the left side of my head.
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| 44 | 2021-03-15 | lip swelling | Swelling of lips, redness. Rash on wrist of lower arm |
| 44 | 2021-03-16 | lacrimation increased, sensitivity to light, vision blurred, eye pain, eye disorder |
I just wanted to pass along my vaccine experience. So, I got the first dose on 25 Jan. Within a da...
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I just wanted to pass along my vaccine experience. So, I got the first dose on 25 Jan. Within a day or two I developed a cold sore. I had not had one in years but it wasn't a big deal. I just figured the foreign vaccine had triggered it from being dormant. Well, I got my second dose on 16 Feb. Within days my eyes started feeling weird...specifically my left eye. It was achy all day, red when I woke up, watery, and it was difficult to focus when I first turned on the lights. This morning I went to the eye doctor and he told me that I had developed a blister (like a cold sore) in my eye. I had never ever ever experienced this. But like the first cold sore on my lip, he said it was dormant in my body and the vaccine just triggered it. There are only two eye drops that treat this and they are pretty expensive but he told me that if I had not come to see him, this virus would have just lingered in my eye. Just thought I would share my experience.
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| 44 | 2021-03-17 | ear pain, pain in jaw |
Chronic, intense pain in left jaw, behind the left ear, and neck pain and headache related to the le...
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Chronic, intense pain in left jaw, behind the left ear, and neck pain and headache related to the left side.
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| 44 | 2021-03-17 | taste impairment |
Light headed and slight dizziness along with string metallic taste in mouth almost immediately follo...
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Light headed and slight dizziness along with string metallic taste in mouth almost immediately following injection. These symptoms dissipated after about 15 minutes and I was able to drive home. An hour later I started to have intense muscle and joint aches all over my body with slight dizziness. My left arm, regardless of continued movement, became increasingly sore. The next morning only slight aches and dizziness remained and I was able to go to work. By the end of the eight hour work day, the joint and muscle aches and fully returned accompanied with intense pain in my left arm, hand, and neck. Today I feel no symptoms at all.
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| 44 | 2021-03-17 | mouth tingling, feeling of choking |
Patient reported tingling in tongue and throat approximately 15 minutes after vaccine administered. ...
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Patient reported tingling in tongue and throat approximately 15 minutes after vaccine administered. Patient was given diphenhydramine.
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| 44 | 2021-03-17 | mouth numbness |
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the ...
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Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
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| 44 | 2021-03-17 | eye swelling |
every where she had had filler injections are swollen except the left eye, her left eye is not swoll...
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every where she had had filler injections are swollen except the left eye, her left eye is not swollen; every where she had had filler injections are swollen except the left eye/her doctor believes she is having a reaction with her fillers/bump on her right eye; under her right eye there was a large bump that was swollen; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration in the left upper arm, on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included Hashimoto's disease from 2017 and ongoing, cosmetic filler injections got in her face within the last year and half or 2 years. Patient said that she knew that Allergan asked her doctor about her ongoing Hashimoto's as well. She takes medication for that. Patient also said that her white blood cell count runs low, like around 2 if they want to note that as an immune system thing and she confirmed that was an issue for her prior to receiving the COVID 19 vaccine. Family medical history included that her daughter has Hasimotos as well. Concomitant medications included unspecified medications for Hashimoto's disease. The patient previously received first dose of BNT162B2 (lot number: EI1685) via an unspecified route of administration in the left upper arm on 18Dec2020 at the year of 44 years at single dose for covid-19 immunisation. She said her doctor believes she is having a reaction with her fillers. She clarified fillers were like cosmetic injections got in her face. She thought the filler was called Allergan but she didn't have any other information about it. She did know her doctor did call Allergan and did a report with them. She thought it was like a big deal because it was not documented with Pfizer just with Moderna. She said the doctor was also going to call and report this as well. The doctor has not called yet but he said he was going to, she just left their office. Basically the places she had had filler injections within the last year and half or 2 years not have, under her right eye there was a large bump that was swollen and then the places that were called labial folds, the marionette lines where she had had filler there were all swollen and that was on the right side of her face and then on the left side the marionette lines were swollen as well so basically everywhere she had had filler injections were swollen except the left eye, the left eye is not swollen. And the places were swollen and hard. She first noticed the swelling yesterday 25Jan2021. The bump on her right eye was yesterday around 15:00 and then this morning (26Jan2021) it was much worse under her eye and she noticed the bumps on the right side at about 6 am this morning and around 9 am she began feeling it on the left side and it progressively has gotten worse since it started in all of those areas (26Jan2021). This case reported as serious. Patient did not visit Emergency Room, but she has been to 2 different physicians in physician office. No other vaccines administered on the same day as either dose of the suspect product. Patient did not have prior vaccinations within 4 weeks. Outcome of the events was not recovered. Reporter assessed event everywhere she had had filler injections are swollen except the left eye, her left eye is not swollen as related to BNT162B2.; Sender's Comments: Based on available information a contributory role of BNT162B2 to reported events cannot be fully excluded. Consideration should also be given to the contribution from the cosmetic filler injections. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-03-19 | thirst |
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I a...
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Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT. I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked. I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
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| 44 | 2021-03-19 | mouth tingling, mouth numbness | Bottom lip numb/tingly. |
| 44 | 2021-03-19 | lip swelling |
Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving ...
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Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving her 2nd dose. Called EMS to her vehicle. Transport ambulance was called to bring patient to ER. Benadryl 50mg IM given by onsite EMS prior to transport.
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| 44 | 2021-03-20 | mouth tingling |
25 min after the vaccine I had left the hospital and was already home. I was unable to swallow. I co...
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25 min after the vaccine I had left the hospital and was already home. I was unable to swallow. I could breathe and talk, but could not feel the Babcock of my throat. My tongue felt like it was swelling but it wasn?t! I tried to drink but couldn?t. This lasted approx 5 minutes and started to subside. All effects cleared 45 -50 min later. The following day I nauseous, throwing up, headache, tired, body aches. Today is totally fine!
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| 44 | 2021-03-21 | dry throat |
Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had cr...
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Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had crawling sensation throughout body and throat felt a little tight/dry. The burning, itching and crawling feeling continued for a couple weeks. Had to take Allegra and Benadryl and currently am still taking it to ward of symptoms.
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| 44 | 2021-03-21 | taste impairment |
Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Ga...
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Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Gave patient one Cetirizine 10mg tablet. Patient refused benadryl and said that she was allergic.
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| 44 | 2021-03-22 | taste impairment |
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea...
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I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
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| 44 | 2021-03-22 | feeling of choking |
Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. ...
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Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. IV was started and patient was given Solumedrol and Benedryl before being taken to ER by EMS.
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| 44 | 2021-03-22 | ringing in ears |
The morning after my dose I woke up feeling like I would pass out while laying in my bed. I believe ...
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The morning after my dose I woke up feeling like I would pass out while laying in my bed. I believe I did since I know the feeling after waking up. Ringing in ears and sweaty. I then began to vomit and contributed vomiting most of the day if I stood up I got dizzy. I could not hold anything down in my stomach. I had fever of 100.0 about 6 pm I began to be able to have a small amount of food in my stomach.
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| 44 | 2021-03-22 | taste impairment |
metallic taste in mouth starting around 11:30 and lasting for 3 hours. Metallic taste went away aft...
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metallic taste in mouth starting around 11:30 and lasting for 3 hours. Metallic taste went away after 3 hours.
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| 44 | 2021-03-23 | ear discomfort |
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe...
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Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
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| 44 | 2021-03-23 | swollen tongue |
Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130...
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Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
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| 44 | 2021-03-24 | mouth numbness |
My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue...
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My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue.
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| 44 | 2021-03-25 | swollen tongue |
15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficult...
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15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficulty breathing. She was then given epi times 1 and benadryl. Symptoms then improved. 20 minutes later symptoms returned and she was given another dose of epi. EMS then took patient to local hospital.
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| 44 | 2021-03-25 | mouth numbness |
Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs...
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Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6199 and expiration date unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 as a single dose for COVID-19 immunization. Medical history included depression, pre-diabetes and known allergies: bee stings. Concomitant medications included loratadine (LORATADINE), metformin (METFORMIN), paroxetine (PAROXETINE), and bupropion hydrochloride (WELLBUTRIN), and "Mul". The patient had no other vaccine in four weeks. On 09Mar2021 at 15:15, The patient experienced dizziness, numb tongue, difficulty swallowing, difficulty breathing, and inability to move arms and legs. The patient had no COVID prior vaccination and had not tested post vaccination. Therapeutic measures were taken as a result of the events which included Epinephrine, ER treatment, and Prednisone. The outcome of the events was resolving. The events resulted in: Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).
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| 44 | 2021-03-25 | burning mouth syndrome | Gum sensitivity and swelling, oral mucosa swelling, tongue sensitivity and irritation. |
| 44 | 2021-03-25 | eye twitching |
I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had di...
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I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.
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| 44 | 2021-03-25 | swelling of eyelid | Kidney pain, Fatigue, Swollen eye lids, Severe dry skin, Itchy skin. |
| 44 | 2021-03-25 | swollen tongue | Patient noticed swelling of her tongue. No SOB or other symptoms. VSS. |
| 44 | 2021-03-25 | lip swelling |
pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn...
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pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn't. Nurse asked her to see the injection site. When she took off her sweatshirt, stating she felt on fire, the site and her arms were extremely red. She was asked to remove her mask and we discovered her lips and area around her nose was starting to swell. At that time she stated that her tongue felt "weird". Assessing the situation, the nurse administered an Epi-pen while I dialed 911 and gave information. Epi-pen very helpful, to the point she "wished we hadn't called the ambulance" . Once the EMTs arrived, they assessed her and after some time, had her sign a release form since she declined attention. Pt was informed that she would not be allowed to finish her shift and was asked if someone could come get her. The daughter was on her way. The nurse and I sat with her, watching to make sure she didn't have a rebound reaction which she did not in the hour + we were with her. Daughter arrived, took instruction from the nurse and took her home.
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| 44 | 2021-03-26 | taste impairment |
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra...
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Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
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| 44 | 2021-03-26 | swollen tongue, lip swelling |
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel...
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She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
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| 44 | 2021-03-27 | tongue itchiness, mouth tingling | throat scratchy, tongue itchy, lips tingling |
| 44 | 2021-03-28 | eye irritation |
3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she...
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3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.
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| 44 | 2021-03-30 | ringing in ears, deafness |
6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 day...
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6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) at the age of 44, intramuscularly, administered in the left arm on 15Feb2021 at 15:30 as a single dose for covid-19 immunization. Medical history included covid-19 (If covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); and ibuprofen (ADVIL [IBUPROFEN]) all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 at the age of 44, given intramuscularly in the left arm on 25Jan2021 at 03:30 PM for Covid-19 immunisation. On 22Feb2021, 6 days after receiving the 2nd dose, patient experienced sudden hearing loss and tinnitus in right ear and severe vertigo 8 days after (24Feb2021). Patient was prescribed high dose steroids from doctor. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient was still suffering from hearing loss and tinnitus 3 weeks later. The patient underwent lab tests and procedures which included multiple hearing tests and Magnetic resonance imaging (MRI) both on unknown date with unknown result. The outcome of the event was recovering at the time of the report.; Sender's Comments: Based on known drug profile it is unlikely that the reported sudden hearing loss, tinnitus and severe vertigo were causally related to bnt162b2. These are intercurrent medical conditions. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-01 | vision blurred |
Dizziness, blurred vision, dropping things for 6 days. Could not see up close and then away. motion...
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Dizziness, blurred vision, dropping things for 6 days. Could not see up close and then away. motion sickness
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| 44 | 2021-04-04 | vision blurred | Visible tremors in extremities, difficulty walking, blurred vision, headaches |
| 44 | 2021-04-17 | deafness |
Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a co...
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Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: En 6205), via an unspecified route of administration, administered in arm left on 03Mar2021 19:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were both reported as none. No known allergies. No other vaccine in four weeks, and no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient became deaf in her right ear after receiving the 1st vaccine on 15Mar2021 12:00 with outcome of not recovered. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event that included steroid injections. The patient underwent lab tests and procedures in 2021 which included hearing tests: unknown results, magnetic resonance imaging (MRI): unknown results. The patient received the second dose of BNT162B2 (Lot number: Ep 7534) in the right arm on 24Mar2021.
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| 44 | 2021-04-20 | eye swelling |
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int...
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Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-04-24 | eye pain |
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star...
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PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-24 | eye bleeding |
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eye...
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causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.
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| 44 | 2021-04-24 | ear itchiness |
her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; teste...
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her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; tested positive for Covid; tested positive for Covid; runny nose and sneezing; runny nose and sneezing; itchy ears and itchy throat; itchy ears and itchy throat; trouble breathing at night; This is a spontaneous report received from a contactable consumer (patient). A 45-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP3302) via an unspecified route of administration in left arm on 13Jan2021 at around 14:00-15:00 as single dose for COVID-19 immunization. Patient medical history included high blood pressure from 6-7 years ago and still ongoing. Concomitant medications were not reported. Patient received historical vaccination as first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Lot number: EH9899, via an unspecified route of administration in left arm on 23Dec2020 10:30 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 3Apr2021, she started having allergy symptoms like a runny nose and sneezing, itchy ears and itchy throat and had trouble breathing at night with clinical outcome of not recovered. She states that the doctor told her she had fluid in both of her ears on 5Apr2021 with outcome of event not recovered. she has diarrhea on 06Apr2021, with outcome of event not recovered. She reported that not even two months later, she has tested positive for COVID-19 on 05APR2021. She states that her husband tested positive on 29MAR2021 and she was direct exposed (exposure to SARS-COV-2) due to work she had to quarantine for 14 days, states her daughter tested positive two days after her husband, states neither of them had the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of event not recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-04-26 | ear itchiness, mouth itchiness |
covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; I...
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covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; Itching soft palate area; Itching in ears; mild respiratory trouble; This is a spontaneous report received from a contactable health care professional (patient) and from a Pfizer sponsored program. A 44-year-old female patient of received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) left arm on 22Jan2021 at 17:45 (at the age of 40-years-old) via intramuscularly at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history included asthma and psoriasis. The patient had known allergy to penicillin. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLOVENT), ethinylestradiol,/levonorgestrel (SRONYX) and cetirizine. On the same date, two hours (at 19:00) after administration of first dose the patient had Itching soft palate area, itching in ears and mild respiratory trouble. The patient received treatment with diphenhydramine 25mg. On 29Jan2021, nasal swab RT-PCR COVID test was positive for the patient. Outcome of the events Itching soft palate area, itching in ears and mild respiratory trouble was recovered while outcome of the event was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.
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| 44 | 2021-04-26 | ear pain |
larger red and swollen itching injection spot; patient had larger red and swollen itching injection ...
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larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
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| 44 | 2021-04-28 | mouth numbness, vision blurred |
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal...
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I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
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| 44 | 2021-04-30 | eye pain, eye discomfort, eye bleeding |
It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture wi...
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It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-04-30 | taste impairment |
diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and sh...
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diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go; it was a pressure, painful but pressure; arm a little sore; tired; weird taste in her mouth; got nauseous; tingling pins and needles in her bottom jaw; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:30 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. She added it is to protect herself and she takes care of her mom next month and she had hers and she also works with the public at store and it is the right thing to do to not keep spreading the awfulness. No prior vaccinations within 4 weeks and no additional vaccines administered on the same date as the COVID-19 Vaccine. Medical history included ulcer, irritable bowel with constipation, tired a lot and just that her doctor said to take a multivitamin and knows B and D are good, sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics, risk factors of high blood pressure, overweight, and a smoker. Concomitant medication included linaclotide (LINZESS) taken for irritable bowel with constipation from an unspecified start date (started taking over 5 years ago) and ongoing; hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for high blood pressure from an unspecified start date (started taking over 15 years ago) to 10Apr2021 (stopped taking on 10Apr2021, her last dose was 09Apr2021); colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date (started taking about 1 year ago, after Covid came out and fiance, tested him and it was low and takes because going around) and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy (reported as tired a lot and just that her doctor said to take a multivitamin and knows B and D are good) from an unspecified start date (started about 6months ago) and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for as tired and heart healthy and she heard good things and thought she would try it from an unspecified start date (started about 6 months ago) and ongoing; vaccinium macrocarpon (CRANBERRY) taken for an unspecified indication from an unspecified start date (started 2-3 weeks ago) and ongoing. The patient also concomitantly took "Tantoprazole" (at 40mg once a day by mouth) started taking over 5 years ago and ongoing, states she took it that morning for ulcers; Dietary fiber (at 25 4 grams by mouth once a day) started taking over a year ago and ongoing after she lost her insurance and couldn't get the medication for her irritable bowel and was taking 2 a day and when she got insurance back and the medication back and still takes 1 a day and helps go to the bathroom; chewable immune support formula (by mouth daily) and ongoing and stated that it is like airborne, it has Vitamin C plus 13vitmains and she started taking this about 2 weeks ago VitC plus 13 vitamis started about 2 weeks ago; ongoing Culturelle Probiotic lactobacillus rhamnosus (40 mg) started over a year to a year and a half ago when she lost her insurance and had problems with irritable bowel with constipation and figured it can't hurt to keep taking. The patient added that she was not taking anything new, she has been on them a long time but will list in case the shot counteracts with a medication. The patient further added she was taking Lisinopril HCTZ for the last 15 years and has had high blood pressure for 20 years and was 1st on Capazoid and was changed to this. She states it is in a pharmacy filled see through bottle and the pill had BO3 on one side and LL on the other side. States she stopped taking it, her last dose was 09Apr2021 and the cardiologist switched her to 2 new medications. The Capazoid, she is not sure of spelling, was for about 5 years and it was Captopril and HCTZ and it was 15-20 years ago and she does not know the dose. It was also stated that she took her morning pills the day of the shot but didn't take her 3 afternoon pills. She went to the doctor for a sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics and took that and she had problems going to the bathroom and the prescription for the UTI was too expensive so she got the over the counter and figured she would take Cranberry to keep it at bay. The patient does not know the name of the antibiotic, the dose, NDC, lot or expiry date states it was about 3 weeks ago. The pharmacist told her fiance that the over the counter was just as good as the AZO. It was also reported that the patient previously had prior vaccinations: sore arm with the flu shot, caller does not have name, dose, NDC, lot or expiry to provide. It was nowhere near the soreness from the Covid shot, it hurt to lift her arm. The patient can be heard asking if her fiance would like to make a report about being tired and having a sore arm after his shot. The patient and fiance decline to make a report. No further details provided. It was reported that the patient is calling to report the side effects she had with the 1st vaccine and what she went through after that and have it recorded and see if anyone else is having the same issue. She states if she can get answers that would be great. Her cardiologist can't confirm or deny if what she experienced was from the vaccine. States she had some immediately after and some happened a couple days later. States some of the stuff is on the sheet but not the severe stuff and if we have more information than when she got the sheet it would be great. The cardiologist she saw in the hospital that said he could neither confirm or deny that it is from the vaccine, states her primary is not aware of this. The patient states she didn't report right away as she didn't think it was a big deal and then she had big issues on Friday and she had the vaccine on Monday. The patient got the vaccine on Monday 05Apr2021, her appointment was at 10:35. The patient got the shot and right after the Band-Aid was placed a couple of minutes she got a weird taste in her mouth and she didn't say anything. She has donated plasma and knows there can be a metallic taste and it was just a shot and whatever it was a funny taste. She sat for the 15 minutes and was fine and got in her car and got nauseous and thought maybe she didn't eat so she started to drive and was calling her fiance to see what he wanted to eat. She started to get tingling pins and needles in her bottom jaw and that was weird to her and she told her fiance about it and got off the phone. She got to the place and ate and the nausea got a little better but she still had the tingling in her bottom jaw. She went home and laid down to take a nap. Shen she got up it was gone and everything was fine. The next day her arm was a little sore and she was tired but that is normal. Her fiance got his and he was tired and so she didn't think anything of it, she works 2 jobs, one at home and also at Target and her first day back was 09Apr2021. States most of the day she was fine but on her last break she was having chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go. Her manager and coworkers were worried about her so she went to the urgent care across the street and was told there that she was having signs of a heart attack with her risk factors of high blood pressure, overweight, and a smoker. They gave her 4 baby aspirin and did an EKG and that came back fine and was told she could go up to the ER if she wanted, she asked what that would do and was told they would run blood work. The patient states it was a pressure, painful but pressure. She asked him if this could have to do with the Covid vaccine she got Monday and he said he didn't know but probably not. She told him her symptoms she has listed, the taste, nausea, pins and needles in the jaw and he hung his head and shook it and told her that is another sign of heart issue. The patient went home and laid down for a nap and when she woke up the chest pain was still there and her fiance said she was going to the hospital since the aspirin didn't help and she could go by ambulance or by car. He took her to the ER Friday and they really thought she was having a heart attack and did tests like EKG and X-Ray and those were fine. It was stated that they did a T enzyme for your heart and it was .03 and they said they wanted it below that, that it wasn't bad. She had that test again and it went up so she had a catheter the next day and was told it was not clogged arteries. The patient stated she was diagnosed with coronary vasospasm. It was clarified the name of the test as Troponin and it was .03 and they wanted it below that and had her stay for observation and said it can go up and is a sign of heart damage and heart attack 6-24 hours after the initial pain. The patient stated they gave her nitroglycerin and that helped with the chest pain and it opened all the blood vessels. Throughout the night her Troponin levels went up. She had a cardio cath Saturday and the cardiologist was surprised he thought there was blockage and would place a stent and there was not blockage and nothing wrong. He explained that her blood vessels were so constricted that her heart spasmed as it was not getting enough oxygen and was causing the pain. She asked him if it could be from the Covid vaccine and he said he could not confirm or deny as she is overweight, has high blood pressure and smokes but she has never had issues before. The reason she is calling is because the tingling in the bottom jaw started within 30-45 minutes after the vaccine and she had never had that before and she is not saying it is related or not. This may help other people may be having issues and may help give information to say maybe you shouldn't smoke right after the vaccine or if you have high blood pressure or are overweight you should stay longer. For the next one her cardiologist thinks she should get the 2nd one and she will pay more attention to the signs. She has an appointment tomorrow with her cardiologist and will double check and ask him as they ask you to let them know before the vaccine if you are on a blood thinner and when her Troponin was up they have her blood thinner Warfarin through the night in the hospital and wants to double check to see if that is still in her system and if it's ok to get the 2nd dose. The physician also changed her blood pressure medication she has been on for over 15 years (No further details provided). The patient added she was hospitalized on 09Apr2021 evening and discharged 10Apr2021 around 5pm. For the investigation the patient states after the heart cath. she had an echocardiogram where you lay on your side and they do an ultrasound of your heart. The patient does not know the result of the echocardiogram, assumes it's fine but doesn't know. She took a week off at work as she was told not to bend her wrist from the procedure and has a weight restriction so she is doing her computer job. It was also reported the normal arm soreness and tired are expected but the severe, it helps to report and keep track of and it may be isolated and it may not be. The outcome of the events was unknown. The events required emergency room and physician office visit.
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| 44 | 2021-05-03 | visual impairment |
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d...
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Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
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| 44 | 2021-05-04 | ringing in ears |
Ringing in ears that started about 2-3 days after 2nd vaccine dose, 2 weeks at this point, seems wor...
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Ringing in ears that started about 2-3 days after 2nd vaccine dose, 2 weeks at this point, seems worse in L ear.; This is a spontaneous report from a contactable physician (patient). A 44-years-old non-pregnant female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318, expiration date unknown) via unspecified route of administration on arm left at a single dose on 31Jan2021 09:45 (age at the time of vaccination 44-year-old) for COVID-19 immunization. The facility type for vaccine was fire station. The patient had medical history of asthma. Patient had no known allergies. The patient received other medications within 2 weeks of vaccination reported as Beclometasone Dipropionate (QVAR), MVI, Ascorbic Acid (Vit C), Colecalciferol (D3), Melatonin, Diphenhydramine Hydrochloride (Benadryl). The historical vaccination patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246, expiration date unknown) via unspecified route of administration on arm left at a single dose on 10Jan2021 10:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 02Feb2021 (started about 2-3 days after second dose) patient experienced ringing in ears after second dose. After 2 weeks at this point seems worse in left ear. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcome of the event as not recovered. Information on the lot/batch number is captured.
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| 44 | 2021-05-07 | dry mouth, taste impairment |
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar...
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almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
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| 44 | 2021-05-11 | tongue itchiness, taste impairment |
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and...
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blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
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| 44 | 2021-05-11 | taste impairment |
blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received ...
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blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates. Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 45 | 2020-12-31 | ear swelling |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2020-12-31 | ringing in ears | Bilateral tinnitus- non stop since the day of the vaccine. |
| 45 | 2021-01-01 | mouth tingling, lip swelling |
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt...
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Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
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| 45 | 2021-01-03 | mouth tingling | Had an episode of tounge tingling and numb throat. Lasted 30 min, resolved without any treatment. |
| 45 | 2021-01-04 | taste impairment |
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin...
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Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
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| 45 | 2021-01-04 | taste impairment |
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ...
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Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
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| 45 | 2021-01-04 | vision blurred |
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde...
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dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-01-05 | lip swelling, lacrimation increased |
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ...
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Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
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| 45 | 2021-01-05 | swelling around the eyes, dry throat |
Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No...
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Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal. After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..
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| 45 | 2021-01-06 | mouth tingling |
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte...
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Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
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| 45 | 2021-01-07 | taste impairment |
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ...
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After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
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| 45 | 2021-01-07 | ringing in ears |
Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare profession...
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Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 21Dec2020 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included chronic sinus infections in the past. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), strength reported as 1/28, azelastine HCI nasal spray, montelukast sodium tablet. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Dec2020 at 12:00 (reported as since the vaccination), the patient experienced bilateral tinnitus (non-stop). The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the bilateral tinnitus (non-stop) was not resolved. Information on Lot/Batch number has been requested.
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| 45 | 2021-01-07 | pain in jaw |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.
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| 45 | 2021-01-07 | bloodshot eyes, eye swelling | Swelling and redness around the eyes and lives. Treatment benadril 50 mg po stat. |
| 45 | 2021-01-07 | mouth tingling, mouth numbness |
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th...
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minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
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| 45 | 2021-01-07 | mouth numbness, mouth tingling | tongue tingling and numb |
| 45 | 2021-01-08 | ear itchiness, mouth tingling, mouth numbness, eye itchiness |
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm...
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I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
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| 45 | 2021-01-10 | eye twitching, eye pain |
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after an...
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About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus) issues and twitching of right eye with some slight right eye pain
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| 45 | 2021-01-10 | swelling of eyelid, mouth numbness, taste disorder |
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ...
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BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
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| 45 | 2021-01-10 | mouth numbness |
Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccina...
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Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccination. Patient reports having taken Benadryl 25 mg PO on her own approximately 1 hr before receiving the vaccine. Another Benadryl 25 mg PO x1 dose adminstered at 9:05am. BP 162/80 HR 64 O2=96% at 09:20am. Lip numbness being reported at 9:20am. Itching subsiding at 9:30am. Patient clinically stable. Patient released from clinic at 9:30am. Patient also reports itching and redness with 1st dose of Pfizer COVID-19 vaccine. Patient also reports having Bell's Palsy after receiving the 1st dose of Pfizer vaccine (with photographic evidence) that was noticed approximately 11 hours after 1st dose of vaccine administration. Patient realized she was having Bell's Palsy after she began noticing having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days) prescribed by her physician. Bell's Palsy resolved in approximately 6 hours.
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| 45 | 2021-01-10 | vision blurred, eye discomfort, sensitivity to light |
Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my...
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Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my glasses off to avoid straining my eye to focus on my computer screen and paperwork. Vision was more blurry without my glasses but could not wear my glasses which made the blurriness worst. Had pressure behind my eyes with a mild headache along with sensitivity to light. The next day 11/05/2021, had my eyes checked by the eye doctor who indicated that everything was normal, eye pressure and response to light. He did put a numbing eye drop in my eye that made the eye pressure relieve for a couple hours but when that wore off, I could feel the pressure behind my eyes. On 11/06/2021, my eye and vision were back to normal
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| 45 | 2021-01-10 | swelling of eyelid, ear pain, mouth numbness |
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda...
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Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
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| 45 | 2021-01-10 | lip swelling | Swollen lips and face hives on face |
| 45 | 2021-01-10 | eye swelling |
Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my ...
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Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my eyebrow. Whites of eyes were still white. They didn't itch or hurt. Went to Urgent care and they recommended cold compresses, Loratadine, Vaseline. About 6 hours later the swelling went down, but not completely. Woke up Sunday morning and my eyelids were dry and scaly.
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| 45 | 2021-01-11 | lip swelling |
Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after ...
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Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after I had waited my 15 minutes I left and it happened in the car and notified the person that gave me the injection and was told to go to Emergency Room. Was told by Emergency Room that I should not have had the injection being allergic to bee stings. Was given IV with Steroid. Discharge papers said Allergic reaction to drug.
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| 45 | 2021-01-11 | eye strain |
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ...
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Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
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| 45 | 2021-01-11 | loss of smell, loss of taste |
Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous repo...
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Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Es1685, expiry date not reported), via an unspecified route of administration on 22Dec2020 at 09:30 AM at single dose for Covid-19 immunization. There were no medical history and no concomitant medications, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines with 4 weeks prior to COVID vaccine nor any other medications within 2 weeks of vaccination. On 01Jan2021, the patient has a cold and headache, she was sent for Covid test 1/5 loss smell/ taste 1/3. The patient did not receive treatment for the events. The patient underwent lab test on 06Jan2021 which included nasal swab: pending result. Outcome of the events was recovered. The reporter assessed the events as non-serious. Information on Lot/Batch has been requested.
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| 45 | 2021-01-11 | dry eye, eye pain |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-11 | oropharyngeal discomfort | scratchy throat, trouble swallowing |
| 45 | 2021-01-12 | mouth numbness, mouth numbness | Systemic: swelling on her throat, numbing lips; symptoms lasted 0 days |
| 45 | 2021-01-12 | swollen tongue |
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin...
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after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
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| 45 | 2021-01-13 | mouth tingling |
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra...
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Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
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| 45 | 2021-01-13 | mouth tingling, feeling of choking |
I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and b...
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I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and burning like it had been scolded. It was reported after 30 minutes. 25 mg of Benadryl was given PO at 2:35. I started to develop a cough and was clearing my throat but had no difficulty breathing. At 3:05 another 25mg of Benadryl po was given. I was monitored until 4:30 PM. I was sent home. By 630 the sensation had started to increase again. I took 25 mg of Benadryl PO again. By 7 PM I was not having any relief so I spoke with my physician and he advised me to take 25 mg of Benadryl PO and the first row of a steroid dose pack. By midnight the symptoms had started to reoccur. I took another 50 mg of Benadryl. I finished the medrol dose pack on Wednesday, January 13th but still have the raw sensation on my tongue.
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| 45 | 2021-01-13 | oropharyngeal discomfort |
c/o foreign sensation in throat immediately after COVID-19 vaccine administered. no signs of airway,...
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c/o foreign sensation in throat immediately after COVID-19 vaccine administered. no signs of airway, breathing or circulation complications. Diphenhydramine 25mg given with resolution of symptom & pt discharged home.
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| 45 | 2021-01-14 | vision blurred |
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati...
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Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
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| 45 | 2021-01-14 | pain in jaw |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
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| 45 | 2021-01-15 | taste disorder, taste impairment |
Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, naus...
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Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, nausea, fatigue, altered taste bitter,
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| 45 | 2021-01-16 | eye pain |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-17 | vision blurred | 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass |
| 45 | 2021-01-17 | eye pain |
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai...
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nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
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| 45 | 2021-01-18 | mouth numbness, mouth tingling |
After 15 min TM started having lip and tongue numbness tingling . Then HA . Allergy to Benadryl ...
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After 15 min TM started having lip and tongue numbness tingling . Then HA . Allergy to Benadryl BP137/92 HR 78 O2 99%
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| 45 | 2021-01-18 | eye swelling | Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia |
| 45 | 2021-01-18 | thirst |
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ...
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Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
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| 45 | 2021-01-18 | eye discomfort |
headache that would not go away, like her head would explode; pressure behind her eyes; This is a sp...
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headache that would not go away, like her head would explode; pressure behind her eyes; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ685), intramuscular in her right arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. On 06Jan2021, the patient experienced headache that would not go away, like her head would explode and pressure behind her eyes. Stated that both events started 30 minutes after the shot on 06Jan2021.Therapeutic measures were taken as a result of headache that would not go away, like her head would explode and pressure behind her eyes which included ibuprofen 800 and switched it out with TYLENOL. Outcome of the events headache that would not go away, like her head would explode and pressure behind her eyes was recovered on 09Jan2021.
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| 45 | 2021-01-19 | mouth numbness |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | eye swelling |
Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at...
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Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at 2am (approx 14 hrs after injection), took 1000mg ibuprofen w water, sleep. Woke up w L eye swelling (have photos), appears L sinus inflamed, more ibuprofen. Effects continued into Sunday, relieved w ibuprofen, swelling of eye went down. Remained tired and achy throughout Monday 01/18 and Tuesday 01/19, woke up Wednesday 01/20 w L sinus stuffiness and "full" feeling, feels like a 1 sided sinus infection.
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| 45 | 2021-01-19 | visual impairment |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-19 | mouth tingling |
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are...
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pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
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| 45 | 2021-01-19 | eye swelling, lip swelling |
swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 ...
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swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 swelling of upper lip took Benadryl and it went away on its own a few hours later. Random hives all over body all weekend From 1/15/21 to 1/18/21. Generalized itchy feeling of skin.
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| 45 | 2021-01-20 | mouth tingling |
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di...
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Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
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| 45 | 2021-01-20 | eye pain, ringing in ears |
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b...
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Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
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| 45 | 2021-01-20 | mouth numbness |
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl...
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Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
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| 45 | 2021-01-20 | visual impairment |
approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilater...
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approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilaterally, as well as clammy hands and light headedness. She also said her eyes were foggy. Vital signs monitored and o2 given per mask. She c/o frontal area head pain, resolved after being on O2 for 5 minutes. 4:05pm says clamminess in hands and light headedness improved. She was release to drive home and told to report to ER if she has any more problems. client does report today of having daily headaches since she received her shot.
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| 45 | 2021-01-23 | feeling of choking, taste impairment |
Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks nu...
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Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks numb and swollen feeling.
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| 45 | 2021-01-23 | ear pain, ear swelling |
My right arm broke out in hives a few hours following the injection, and then my left arm a few hour...
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My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.
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| 45 | 2021-01-24 | thirst |
About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extr...
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About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extreme thirst, temperature of 100.1. The next morning she had a temperature of 101.2 with improvement of the chills but ongoing headache and body aches.
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| 45 | 2021-01-24 | mouth tingling, swelling around the eyes |
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m...
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About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
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| 45 | 2021-01-24 | thirst |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-24 | eye swelling, inability to speak |
Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eye...
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Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling
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| 45 | 2021-01-24 | mouth tingling, swollen tongue |
Pt waiting in Observation had vaccine at 17:47 - 2nd dose - 18:00 c/o tingling around lips and the...
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Pt waiting in Observation had vaccine at 17:47 - 2nd dose - 18:00 c/o tingling around lips and then tongue swelling Had 50 mg of benadryl IM to left deltoid at 18:04 18:13 BP 108/80 HR 100 Pulse ox on RM air was 96% 18:15 HR 104 on monitor BP 110/80 18:21 Transported by Wheelchair to ED for further evaluation
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| 45 | 2021-01-24 | inability to speak |
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she...
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Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
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| 45 | 2021-01-25 | mouth tingling |
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out...
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Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
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| 45 | 2021-01-25 | swollen tongue |
Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for...
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Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for 30 min to monitor for reaction. After 5 min, patient reported feeling dizzy, tongue feeling slightly swollen, chills, slight difficulty swallowing her own saliva. She denied difficulty breathing, racing heart. NP on site notified, who performed a focused assessment and administered 50 mg IV Benadryl IM. Patient was reassessed and monitored by NP and two RN. Patient reported instant symptom relief within 2-4 min, that her chills went away and no issues swallowing and felt "90%" better. After 15 mins patient reported she was feeling symptoms again come back. Patient was escorted to the ED with NP and RN immediately.
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| 45 | 2021-01-25 | pain in jaw |
Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair...
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Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair, reports immediately after receiving vaccine feeling flushed and shaky, BP checked 172/95 MAP 115. Denies PMH of HTN, reports baseline BP 120s-130s/60s-70s. Denies CP/SOB or throat scratchy/swelling but does report jaw pain. Reports only allergy is to PCN, last meal was a protein shake ~1 hour prior. Symptoms did not resolve when placed in supine position, reported the feeling of ?flushed? worsening. Decision made to transfer patient to ED for further evaluation. ED work-up negative. Was observed for one additional hour in ED and discharged to home. No further symptoms documented in ED.
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| 45 | 2021-01-25 | dry mouth |
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho...
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Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
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| 45 | 2021-01-25 | loss of taste, loss of smell |
started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; Thi...
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started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. The patient's patient medical history and concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday. She stated on Sunday (10Jan2021) that she started feeling like she could not smell and did not have flavor and it was getting worse on Sunday and Saturday. She does not have no fever, no headache, nothing from Covid. She stated she received a Covid test and the test was negative. She called to see if this is a side effect of the vaccine. The patient further mentioned that she has no smell or taste and wanted to know if it is related to the vaccine. She mentioned that she does not have any other COVID symptoms and she had a COVID test that was negative on an unspecified date. The outcome of the events was not recovered. The following information on the batch/lot number has been requested.
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| 45 | 2021-01-26 | mouth tingling |
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei...
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Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
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| 45 | 2021-01-26 | feeling of choking |
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR ...
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Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR 66 bpm. Given apple juice and didn't feel lightheadeness or tnling. Then expressed waves of episodes reported by the patient. Monitored for 117 minutes. PRovider called 1 hour after monitoring symptoms that were not worsening. Still felt shakey. Given option to go to ED or be transported by ambulance. Went via ambulance to ED. Did not receive any additional treatment in the ED. ED noted that it did not appear to be anaphylactic reaction.
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| 45 | 2021-01-27 | ear swelling, swelling of eyelid |
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ...
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1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
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| 45 | 2021-01-27 | ear pain |
Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very...
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Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very sore; left earache; back and neck pain; back and neck pain; Fever 102; Chills; Body aches (muscles and joints); This is a spontaneous report from a contactable consumer (patient herself). This 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL33029), via an unknown route, on 16Jan2021 (at 09:45) at single dose administered on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high blood pressure, asthma and COVID-19 (prior to vaccination). The patient was receiving concomitant medications (unspecified). On 17Jan2021 (at 08:00 AM), the patient developed fever 102, chills, body aches (muscles and joints), tiredness, weakness, left arm very sore, left earache, back and neck pain. It was unknown if the patient received treatments for the events. The patient was recovering from the events.
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| 45 | 2021-01-27 | loss of taste, loss of smell |
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patie...
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COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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| 45 | 2021-01-27 | dry throat |
Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevate...
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Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevated BP however patient noted that it was because she was anxious. Symptoms resolved within 30 minutes and patient left the clinic.
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| 45 | 2021-01-27 | mouth tingling |
Patient is a nurse and received her 2nd COVID vaccine dose 1/25/2021. She knew she was at risk for a...
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Patient is a nurse and received her 2nd COVID vaccine dose 1/25/2021. She knew she was at risk for anaphylaxis so she was kept under observation at the vaccine administration site. Ten minutes after receiving her shot she felt her lips starting to tingle along with lightheadedness. She did not have any other symptoms. She was given 50mg IM benadryl, and the patient was transported to the emergency department. Her symptoms resolved after receiving benadryl. After being evaluated in ER, where no further treatment was warranted, she was discharged with Pepcid, prescription for 4 days of prednisone, and EpiPen. She was given a referral to allergy clinic.
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| 45 | 2021-01-27 | lip swelling, swollen tongue |
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive...
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Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
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| 45 | 2021-01-27 | taste impairment |
half of my legs feel uneasy; had bad taste like metal; This is a spontaneous report from a contactab...
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half of my legs feel uneasy; had bad taste like metal; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8482, expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 12:00 at a single dose for COVID-19 immunization. Medical history included history (Hx) of blood clots. The patient has no known allergies. The patient is not pregnant. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medication in two weeks. The patient had no COVID prior vaccination and had not tested post vaccination. On 14Jan2021 at 1315, the patient experienced half of her legs felt uneasy, no pain, just like she worked out. The patient also reported that after the vaccine, she had a bad taste, like metal. No treatment was administered for the events. The events had not resolved.
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| 45 | 2021-01-28 | mouth tingling, swollen tongue |
Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 ...
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Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 mg IM given at 1252 without relief. Pt still reporting feeling of tongue swelling. Rash developed on neck and arms. Per protocol second dose of Benadryl 25 mg administered with slight relief at 1315. Epinephrine 0.3 ml administered at 1315 with no relief. Symptoms still persist. Second epinephrine dose administered at 1322. EMS notified and arrived at 1329 to transport pt to Northwestern Hospital.
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| 45 | 2021-01-28 | eye itchiness |
Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck an...
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Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck and chest are red. Pt. had Covid in Oct. 2020, blood drawn showed no anti-bodies 3 weeks prior the vaccine.
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| 45 | 2021-01-28 | swollen tongue, lip swelling |
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike...
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Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
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| 45 | 2021-01-29 | tongue disorder, oropharyngeal discomfort |
Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl...
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Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl given 25mg IM per protocol, patient thought felt slightly better. Tongue swelling reduced per patient. Patient rested, appeared comfortable. Vital signs improved. Tongue swelling appeared to be large, epi given x2, Throat still uncomfortmatble. Tongue appeared swelling. EMS activated 1:23pm. EpI 1.23mg IM repeated, rash bilateral now, patient able to swallow. Benadry .5mg IM given for a total of 50mg.
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| 45 | 2021-01-31 | mouth tingling, mouth numbness |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
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| 45 | 2021-01-31 | mouth numbness, mouth tingling |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
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| 45 | 2021-01-31 | mouth tingling |
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT...
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DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
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| 45 | 2021-01-31 | mouth swelling, mouth numbness |
Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different ...
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Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment at the ER where she received prednisone and valacyclovir for one week treatment.
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| 45 | 2021-02-01 | ear pain, hearing loss, ear discomfort |
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per fami...
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Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per family report starting complaining about L ear pain on Friday 1/29, On Sunday 1/31, started to experience dizziness and some L ear discomfort, Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear. Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch". Tuesday AM contacted three MDs, concerns of shingles. Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics. Pain and dizziness at work Tuesday morning however its only Tuesday night. Pain/burning still very intense.
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| 45 | 2021-02-01 | vision blurred |
Light headed, blurred vision. BP/pulse: 139/92, 63; 145/82, 57. O2 sat 99%-100%. History of anxiety ...
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Light headed, blurred vision. BP/pulse: 139/92, 63; 145/82, 57. O2 sat 99%-100%. History of anxiety disorder. Stable, discharged to home.
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| 45 | 2021-02-01 | oropharyngeal discomfort |
Patient informed vaccinator about previous allergic reaction to dose 1 that spontaneously resolved, ...
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Patient informed vaccinator about previous allergic reaction to dose 1 that spontaneously resolved, was instructed to stay 30 minutes for monitoring. Reports no adverse events to any vaccines in the past, including the flu vaccine. She received dose 2 Pfizer COVID vaccine at 10:57 am, started experiencing throat discomfort at 11:25 am (BP 146/65 HR 96), and was given 50mg IM Benadryl. Five minutes later, patient reported an improvement. Vital signs remained stable throughout observation. BP 126/85 HR 83 at 11:40 am and BP 120/84, HR 60 at 12 pm.
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| 45 | 2021-02-02 | eye itchiness, mouth tingling |
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute...
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Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
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| 45 | 2021-02-02 | mouth tingling | Paresthesias of mid-portion of upper lip and headache onset 30 mins after COVID-19 Vaccine given |
| 45 | 2021-02-02 | eye twitching |
Since the vaccine I have experienced tingling of lips and face. The past few days I have started exp...
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Since the vaccine I have experienced tingling of lips and face. The past few days I have started experiencing more tingling/twisting sensations on left side of body and some weakness of left side of body as well as twitching of left eye.
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| 45 | 2021-02-02 | mouth numbness, mouth tingling |
numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given be...
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numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given benadryl, sx's started improving a couple hours later.
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| 45 | 2021-02-02 | loss of taste, ringing in ears, loss of smell |
symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and te...
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symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and terrible headaches, very mild nasal congestion, chills, and a rash on my chest. On Monday, 1/11/21 I was tested for COVID and positive as I was still not feeling well and lost my taste and smell. I can?t recall if I lost taste and smell on the 10th or the 11th. Those first few days I slept most all day and the days run together a little bit. I think maybe mid week, I started with tinnitus. About Wednesday, Jan 13th, I started with what looked like chicken pox mostly on my legs and back- these were itchy and fluid filled. Symptoms were starting to improve on Thursday Jan 21st in regards to my ?pox? as I think it was that day where I did not have any new ones that developed. My fatigue and headaches started to improve that day or the Friday after as well. I still notice some fogginess or mild memory issues, tinnitus is better but not fully gone, taste and smell are returning, fatigue continues to improve, headaches are intermittent.
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| 45 | 2021-02-03 | eye disorder |
27th January 2021-Stuttered, right eye drooping-in the ER-patient is and employee of the staff. The ...
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27th January 2021-Stuttered, right eye drooping-in the ER-patient is and employee of the staff. The providers in the ER did a quick neuro check/test-27th January 2021. Outcome-she can smile, can blink and has no stutter today 4 February 2021
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| 45 | 2021-02-03 | visual impairment |
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more...
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impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-04 | ear pain |
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms...
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My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
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| 45 | 2021-02-05 | feeling of choking, mouth tingling, mouth discomfort, tongue discomfort |
15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue...
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15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue, lips tingling and burning. After a couple hours my nose felt numb and tingly inside and stayed like that until the day after. The day after i had the vaccine if I try to eat it flairs the burning fizzing feeling in my mouth and lips again. Feel week and tired, headaches and body pain. Im concerned with the mouth stuff though before getting the second dose.
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| 45 | 2021-02-07 | dry mouth |
1000-employee received vaccine 1005:employee relates a very dry mouth and possible difficulty swallo...
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1000-employee received vaccine 1005:employee relates a very dry mouth and possible difficulty swallowing(kind of like reaction to shellfish); 1030employee checks in to ED for further evaluation; 1100 employee discharged from ED
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| 45 | 2021-02-07 | mouth tingling, feeling of choking |
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl...
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Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
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| 45 | 2021-02-07 | lip swelling, tongue itchiness |
Patient developed itching of tongue and upper lip swelling after receiving the pfizer COVID-18 vacci...
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Patient developed itching of tongue and upper lip swelling after receiving the pfizer COVID-18 vaccine. The patient developed symptoms while in the monitoring phase after vaccination. Employee waited 30 minutes after vaccination and then spoke with POD physician explaining the symptoms. POD physician recommended taking some benadryl. The employee was planning to drive home so a 25 mg table of benadryl was given to her to take with her/take on way home. Patient did not take the medication at the POD. Patient stated the symptoms had improved.
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| 45 | 2021-02-07 | mouth tingling |
Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from...
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Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from 1:25pm-2pm when she stated that she was ok and wanted to go. Pt was initially offered 911 transport but declined. Pt then went to her car and felt worse. Re presented to the clinic and then 911 was initiated.
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| 45 | 2021-02-08 | vision blurred |
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues wit...
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Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
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| 45 | 2021-02-08 | sensitivity to light | Fever 102.2, chills, extreme body aches, stomach cramps, headache with light sensitivity. |
| 45 | 2021-02-08 | dry mouth |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-09 | taste impairment |
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report...
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metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
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| 45 | 2021-02-10 | eye pain, pain in jaw |
Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind...
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Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind me eye, moderate chills, mild nausea maybe due to the pain. Symptoms started 2/10/21 at 6pm and progressively got worse to the point of being unable to sleep. Took Tylenol at 1:30am and the pain decreased and was able to sleep some, 4 hrs later symptoms returned. Took more Tylenol. 2/11/21 5:57pm still have mild sore arm, mild headache off and on and mild chills.
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| 45 | 2021-02-12 | deafness, deafness unilateral |
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profoun...
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Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
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| 45 | 2021-02-14 | dry mouth, mouth tingling |
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advise...
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Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time. 1742: "Fire feeling" began to resolve. 1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
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| 45 | 2021-02-14 | mouth tingling |
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n...
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stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 45 | 2021-02-15 | pain in jaw, ear pain |
Client woke on Thursday 02/11 at 0700 to left sided ear, jaw pain, sore throat and unable to open he...
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Client woke on Thursday 02/11 at 0700 to left sided ear, jaw pain, sore throat and unable to open her mouth. Also has a prior neck injury that began to have neck pain to be more prevalent going toward her back. She did not seek medical attention for these symptoms. Today client continue to have left ear discomfort and jaw is still sensitive to touch. Sore throat went away this morning and she is feeling better than before.
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| 45 | 2021-02-16 | swollen tongue, mouth tingling, mouth discomfort, oropharyngeal discomfort |
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin...
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Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
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| 45 | 2021-02-16 | swollen tongue, mouth numbness, mouth tingling |
shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling...
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shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips
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| 45 | 2021-02-18 | inability to speak |
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi...
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Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
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| 45 | 2021-02-18 | swollen tongue |
at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She do...
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at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She does report a sensation of feeling like difficulty breathing or swallowing and is initially treated with Solu-Medrol and Benadryl as well as IV fluids. She reports that symptoms are improving almost immediately after meds are pushed. As result epinephrine is initially deferred for continued monitoring. However upon reassessment approximately 1 hour after reported reaction, the numbness in the hands and feet have resolved, but she is complaining that she feels as though the back of her tongue is swollen and still making it difficult to swallow though she no longer feels short of breath. As a result, we have discussed the possibility of treatment with epinephrine in order to fully resolve symptoms, and she is agreeable to proceed. ,
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| 45 | 2021-02-22 | visual impairment | Nausea, vertigo, ataxia, falls, change in vision persisting currently |
| 45 | 2021-02-22 | dry mouth |
The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny f...
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The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain." The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol
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| 45 | 2021-02-24 | thirst |
pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal a...
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pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed. IV started. pt then taken to local hospital for further eval.
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| 45 | 2021-02-25 | sensitivity to light |
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runn...
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Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite . Extreme sweating. Extreme sweating of the under arm is still and issue. No fever now.
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| 45 | 2021-02-25 | mouth tingling |
Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of fa...
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Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
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| 45 | 2021-02-28 | swelling around the eyes, eye itchiness |
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di...
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Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
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| 45 | 2021-02-28 | eye itchiness |
Light headed and headache and that subsided about an hour later. For the next couple of weeks, I had...
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Light headed and headache and that subsided about an hour later. For the next couple of weeks, I had a rash on my eyelids and bumpiness and itchiness for my upper eyelids and it eventually went away. I used antihistamine and that helped a little and then it came back.
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| 45 | 2021-03-01 | mouth tingling |
45 yo female with h/o htn c/oed of tingling of lips 13 min after covid vaccination. pt denies rash,...
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45 yo female with h/o htn c/oed of tingling of lips 13 min after covid vaccination. pt denies rash, hives, fludhing , chest pain, palpitation, gi sx or dizziness pt with stable vital signs exam unremarkable : esp no angioedema and no stridor or wheezing . most likely anxiety attack wtih parathesia which resolved after 50 min observation without intervnetion other than reassurance
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| 45 | 2021-03-02 | eye movement disorder |
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes...
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Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
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| 45 | 2021-03-02 | eye pain |
dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable heal...
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dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 14Jan2021 at 12:30 PM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 26Dec2020 at 03:30 PM (at the age of 45 years old) at the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 16Jan2021 at 09:00 AM, the patient experienced dizziness and achiness behind her eyes for 16 days. The patient did not receive treatment for the events. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab: Negative on 31Jan2021. The outcome of the events was not recovered.
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| 45 | 2021-03-03 | mouth tingling, mouth numbness |
Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccinati...
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Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccination and continues now 6 days later. Does not seem to have abated at all. Face feels flushed all the time.
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| 45 | 2021-03-04 | taste impairment, tongue disorder |
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. The...
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Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
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| 45 | 2021-03-04 | ear pain |
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ...
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rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-03-07 | mouth numbness | Headache, numb tongue and numb bottom lip and numb bottom part of mouth |
| 45 | 2021-03-07 | mouth numbness |
The patient felt fine after the vaccine at 12 noon on 03/05, she woke up on 03/06 at about 6:00 a.m...
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The patient felt fine after the vaccine at 12 noon on 03/05, she woke up on 03/06 at about 6:00 a.m. and noted numbness around her mouth and jaw, that felt similar to the numbness one experiences after going to the dentist. However, the patient has not gone to the dentist at all recently. This lasted most of the day and then mostly self-resolved. She still has a little bit of numbness around her lips. She never had any sensation of her throat closing up. She did not need to use an EpiPen. She is a bit concerned about getting her 2nd vaccine and if this will occur again.
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| 45 | 2021-03-07 | taste impairment |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-07 | inability to speak |
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S...
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thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
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| 45 | 2021-03-09 | swelling of eyelid |
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che...
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I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
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| 45 | 2021-03-12 | mouth tingling |
Patient felt tingling around mouth, lips, tongue and "gum tightening." Given 10mg Zyrtec and after 1...
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Patient felt tingling around mouth, lips, tongue and "gum tightening." Given 10mg Zyrtec and after 15 minutes symptoms began to subside more. Tingling is now minimal. Will discharge home.
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| 45 | 2021-03-14 | lip swelling | SWELLING LIPS, NAUSEA AND HEADACHE. NOT FEELING WELL. |
| 45 | 2021-03-15 | lip swelling, mouth swelling, swelling of eyelid |
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. ...
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After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
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| 45 | 2021-03-15 | loss of taste |
No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient her...
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No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration on 30Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation in hospital. The patient's medical history was unknown. It was unknown whether the patient had allergies to medications, food, or other products or not. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), on 09Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation and felt tired, lethargic all weekend. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination or not. On 30Jan2021, the patient experienced no taste, fever and migraine. The patient underwent lab tests and procedures included body temperature: Fever on an unspecified date. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-03-16 | ear pain |
I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle ...
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I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle soreness, had fever of 99.4F and thought it was menopausal symptoms. After my second dose vaccine, my lymph nodes were visibly enlarged. I experienced muscle soreness, lymph nodes were enlarged, left side, had chills, sore throat, ear ache radiated towards my neck and had a viral pink eye. I felt very tired and had muscle aches. I had a fever of 99.4F, mostly chills and joint pain to my left shoulder, left hip and left knee. I also had 3 Covid swab testes which were all negative. I saw my doctor who performed a x-ray of the chest and has put off a mammogram test till April 2021. At this time I have not recovered there is something going on with my pelvis, form my iliac crest when bending down I feel a pinched lymph node on that area of iliac crest. I get a pinch on my pelvis that is painful.
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| 45 | 2021-03-16 | dry throat |
Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or tro...
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Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or trouble breathing. Benadryl 25mg PO x 1 given, pt also took 1 puff of albuterol, throat symptoms resolved, then pt developed dizziness/jitteriness. Pt monitored and symptoms resolved. Pt discharged home with family under stable condition. Respirations unlabored and even. SpO2 100% RA BP 126/61 HR 85
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| 45 | 2021-03-16 | feeling of choking | Tingling back of throat and tip of nose. Dizzy on standing. |
| 45 | 2021-03-17 | lip swelling, swollen tongue |
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vac...
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Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.
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| 45 | 2021-03-17 | lip swelling |
Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-he...
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Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-headed/dizzy. She appeared frightened and after a couple of minutes felt as if her lips were beginning to swell. Patient was offered and received benadryl liquid orally and felt better after 15 more minutes and left after declining any additional treatment.
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| 45 | 2021-03-18 | vision blurred |
3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: . BLURIED VISION Assessment : Time of assessment . 1034AM Actions taken: VS TAKEN, BP-130/89, HR-72, O2 100%, WATER OFFERED AND DRINKING, ENCOURAGED TO EAT AS SHE VOICES THAT SHE HAS NOT HAD FOOD TODAY, HAD DRIVER WITH HER. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for . minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 10:00 AM 0.3 mL 12/11/2020 Intramuscular
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| 45 | 2021-03-20 | lip swelling, mouth tingling |
Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injecti...
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Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).
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| 45 | 2021-03-21 | swelling around the eyes |
About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, ...
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About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, firm, swollen and red.
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| 45 | 2021-03-21 | taste disorder, smell distorsion |
About 3 weeks ago, I began to notice that coffee smelled odd. Since then, my sense of taste and smel...
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About 3 weeks ago, I began to notice that coffee smelled odd. Since then, my sense of taste and smell have increasingly worsened to the point that I am extremely nauseated. It is awful.
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| 45 | 2021-03-21 | visual impairment, eye pain |
MAY NOT BE CONSIDERED ADVERSE EVENT BUT WANTED TO REPORT IT: About 10 minutes after shot I experienc...
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MAY NOT BE CONSIDERED ADVERSE EVENT BUT WANTED TO REPORT IT: About 10 minutes after shot I experienced a sharp pain in my bottom right occipital lobe/base of skull. Later only about 1 min. Also experienced tingling sensation in my eyes and vision interference that lasted about 20 seconds tops. Immediately following, however, my vision appeared sharper. I also experienced sharp pain about a few hours later in bottom left occipital/base of skull that only lasted about 30 seconds. Other than that I feel great! Given the newness of the vaccine I felt it important that you know.
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| 45 | 2021-03-21 | blindness, vision blurred |
With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. B...
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With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. By the next morning I was numb from the neck down and my vision went in my left ye and very blurry in the right eye.
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| 45 | 2021-03-21 | lip swelling, lip itchiness |
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in...
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Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
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| 45 | 2021-03-21 | mouth tingling |
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st...
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after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
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| 45 | 2021-03-22 | visual impairment |
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he...
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5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
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| 45 | 2021-03-22 | oropharyngeal discomfort, tongue discomfort, swollen tongue, mouth discomfort |
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ...
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Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
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| 45 | 2021-03-22 | ear pain, toothache |
First dose: mild lethargy, mild body aches. lasted for 12 hours. Second dose: Injected at 8 a.m. 4 p...
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First dose: mild lethargy, mild body aches. lasted for 12 hours. Second dose: Injected at 8 a.m. 4 p.m.: lethargy, headache, earache, toothache 6 p.m.: severe body aches, severe lethargy, severe chills, temperature rose by 2 degrees,cough, headache, dehydration, dizziness, earache, nausea, woke up every hour, lasted till 12 p.m. next day. 12 p.m.: temperature (2 degrees), moderate chills, moderate body aches, dizziness, severe sweating, dehydration 7 p.m.: no temperature, dehydration, dizziness, mild body aches, no chills, moderate sweating 7 a.m.: no temperature, dehydration, dizziness (mild), no body aches, lethargy (mild), no chills, mild sweating Since then still tired but improving.
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| 45 | 2021-03-22 | mouth tingling |
My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water help...
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My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water helped get it to the 80-90 range. When first receiving the shot I started feeling numbness in left hand. Tingling in mouth. Altogether my left side felt weird the first hour at least.
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| 45 | 2021-03-22 | smell distorsion, loss of taste |
On the day after my vaccine I was sweating all day but did not think anything of it. By the end of ...
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On the day after my vaccine I was sweating all day but did not think anything of it. By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot. I was sweating but freezing at the same time. I changed my clothes and went to bed. I then began freezing where I my teeth were chattering and could not get warm. I had on 3 blankets and was shaking. I fell asleep and was having hallucinations and talking to my grandparents that are deceased. I woke up not know anything but what I was told by my husband and daughter. I took my temperature and it was 104.1. I then continued to alternate between tylenol and ibuprofen for the rest of the night. I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th. I still had a fever but developed a headache that nothing was helping. my fever was 101.4. I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab. I was in bed for the next 12 days and everyday I was developing various symptoms. By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away. I was our of work from 01/12/21-01/25/21.
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| 45 | 2021-03-23 | pain in jaw |
Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain M...
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Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
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| 45 | 2021-03-24 | eye irritation, mouth discomfort |
At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for sev...
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At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for several hours. I went straight to the ER when it started. Every day since then I have had several shaking episodes lasting in length from 30min to 2 hours. After I get a horrible headache and feel exhausted.
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| 45 | 2021-03-24 | eye disorder |
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine...
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Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
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| 45 | 2021-03-24 | vision blurred |
I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even ...
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I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even walk straight the vertigo was so severe. Monday the cold symptoms were much better mostly fatigue and I still had vertigo but not as bad. To this day I still have the vertigo. When I get up or down from a laying position the room spins. If I lean my head back even when I'm standing the room spins. If I stand too long I get a fuzzy feeling. My vision is also a bit cloudy than before.
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| 45 | 2021-03-24 | dry mouth |
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being...
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Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
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| 45 | 2021-03-25 | pain in jaw |
Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in priva...
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Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in private recovery area Client initially stated that it felt like she had swelling in her jaw area and neck Client reports no difficulty breathing At 2:35 After further questions the client states that a better word would be tightness. No swelling noted Client reports left sided jaw tightness and tightness and stiffness in the neck (just below her left ear) Vitals taken : BP 138/99, Pulse 106, O Sat 98 Client states that it feels like when she has TMJ Client reports feeling a flushed sensation go up her arm towards her jaw and neck after the injection At 2:40 Client reports that the pain/ tightness in her jaw has lessened and no longer feels like its building Client was previously given water Client reports no difficulty breathing and No sensation of her throat closing At 2:42 Client states that when she has issues with TMJ she normally takes Benadryl which helps One 25mg tablet of Benadryl was given with a sip of water Client is not driving and came with her husband. Her husband will drive Client reports feeling like its calming down I let her know that she didn?t have to leave immediately and could still sit At 2:49 Client reports feeling better than when she arrived in the private recovery area Vitals taken: BP 134/105, Pulse 105, O Sat 99 A few minutes later her husband arrived At 2:57 Client reports feeling well enough to leave Client was driven today by her husband Client was advised to seek further care via call 911 if symptoms worsen or difficulty breathing Client able to ambulate to the car unassisted
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| 45 | 2021-03-25 | swollen tongue |
Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 app...
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Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 approximately 11:53am at the Vaccination Clinic at the Medical Center. While waiting in the parking lot, patient honked her horn and alerted medics she was not feeling well. Reaction occurred at approximately 12:40pm. Patient had tongue swelling, racing heart, and lightheadedness. Medics took vital signs and administered 0.3ml Epinephrine IM. Patient was transported to Medical Center.
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| 45 | 2021-03-25 | eye swelling |
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la...
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Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
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| 45 | 2021-03-26 | eye pain, swelling of eyelid |
After adminstaration of vaccine, patient had sharp pain behind the eyes and patient claim to have sw...
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After adminstaration of vaccine, patient had sharp pain behind the eyes and patient claim to have swollen eyes lids. Paramedic came and took vitals signs and ekg. Patient symptoms subsided. She state she was fine and she was release by the nurse.
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| 45 | 2021-04-08 | ringing in ears | Tinnitus developed four days after receiving second dose of vaccine. No history of tinnitus. |
| 45 | 2021-04-09 | mouth numbness |
lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; s...
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lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; soreness/pain in the arm after the injection; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 (received at 45-years-old) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine at noon on 05Mar2021. She stated that 18 hours later, when she woke up the next morning on 06Mar2021, she had numbness around her mouth area that spread to the left cheek area. She said it was like going to the dentist and getting local anesthesia for a filling. Her lip area looked a little droopy, but she wasn't sure. It continued the whole day and reduced the next day (07Mar2021). She also had soreness/pain in the arm after the injection (05Mar2021) and the next morning (06Mar2021). She further stated that her doctor wasn't sure if this was a one-time issue or related to the vaccine. Outcome of Her lip area looked a little droopy was recovering, while outcome of the other events was unknown. Information about batch/lot number has been requested.
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| 45 | 2021-04-13 | ear pain |
Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn...
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Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.
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| 45 | 2021-04-21 | ringing in ears |
Tinnitus and ringing in ears, comes and goes but more frequent at night, wakes me up out of sleep, h...
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Tinnitus and ringing in ears, comes and goes but more frequent at night, wakes me up out of sleep, has been happening more consistently over last week and a half
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| 45 | 2021-04-24 | taste impairment |
Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous repor...
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Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous report from a contactable 45years old female consumer (patient). A 45-year-old female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: EL8982) second dose via intramuscular, administered in left arm on 11Feb2021 11:30 AM and first dose via intramuscular, administered in left arm on 21Jan2021 10:15AM (Batch/Lot no: EL3246) as a single dose for COVID-19 immunization. Vaccination administered at living facility. The patient medical history included fibromyalgia, IBS, unknown heart issue causing hypertension. The patient concomitant medications the patient received within 2 weeks of vaccination are Omeprazole, losartan, atorvastatin, metoprolol. The patient underwent lab test and procedures which included COVID-19 tests, Prior to vaccination, was the patient diagnosed with COVID-19 was yes, Since the vaccination, has the patient been tested for COVID-19 was No. Allergies to medications, food, or other products:Sulfa based drugs . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 patient experienced with metal taste still in mouth April. Getting worse, had to seek doctors advice. The outcome of the event was not recovered. No follow-up attempt are needed. further information is expected.
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| 45 | 2021-04-26 | vision blurred |
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness...
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Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
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| 45 | 2021-04-29 | eye swelling |
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side o...
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Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
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| 45 | 2021-05-04 | mouth tingling, mouth swelling |
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha...
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Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-05-07 | swollen tongue |
Allergic swelling of young and throat; Allergic swelling of young and throat; Shakes; Numbness on ri...
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Allergic swelling of young and throat; Allergic swelling of young and throat; Shakes; Numbness on right side of face; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies to gluten and dairy, covid prior vaccination and Mthfr. There were no concomitant medications. The patient has no other vaccine in four weeks and no other medications in two weeks. The patient experienced shakes, numbness on right side of face and allergic swelling of "young" (as reported) and throat on 20Apr2021 at 22:00. The events were treated with Benadryl. The patient was not tested for covid-19 post vaccination. The outcome of the events was recovered with sequel on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-05-09 | ringing in ears, deafness unilateral |
tinnitus for 24 hours, loss of hearing for 48 hours, tinnitus for about 7 days. Received second dose...
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tinnitus for 24 hours, loss of hearing for 48 hours, tinnitus for about 7 days. Received second dose on 2/3/21, Lot# EL3289, tinnitus restarted at about 24 hours post-vaccine. No improvement and tinnitus continues. All symptoms only in right ear.
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| 46 | 2021-01-04 | lip swelling |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | eye swelling |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | vision blurred |
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi...
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Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-04 | mouth tingling, mouth numbness | nausea, numbness & tingling of mouth/tongue |
| 46 | 2021-01-04 | ringing in ears |
ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient...
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ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.
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| 46 | 2021-01-04 | loss of smell |
tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous...
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tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.
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| 46 | 2021-01-05 | taste impairment |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | smell distorsion |
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ...
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Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
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| 46 | 2021-01-05 | mouth itchiness |
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ...
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UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
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| 46 | 2021-01-05 | eye itchiness, dry throat |
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even...
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c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
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| 46 | 2021-01-05 | eye pain, lacrimation increased |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-05 | taste impairment |
now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneou...
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now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp). A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination. The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.
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| 46 | 2021-01-05 | swollen tongue |
the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a...
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the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Arm Left from 28Dec2020 12:45 to 28Dec2020 12:45 as single dose for COVID-19 immunization. Medical history included allergy to Latex and depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient previously took Percocet and experienced allergies. On 28Dec2020 at 09:45 PM, the patient experienced tongue swelling 9 hours after injection. The patient stated had this similar feeling or reaction after taking Percocet when she had her first child. The patient took Benadryl 25mg as treatment to the event. The outcome of the event was recovered. Information about lot/batch number has been requested.
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| 46 | 2021-01-06 | lip swelling, swelling of eyelid |
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris...
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01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
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| 46 | 2021-01-06 | pain in jaw |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | vision blurred |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | mouth numbness |
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he...
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jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-07 | eye pain | Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain |
| 46 | 2021-01-07 | lip itchiness, lip swelling |
Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling an...
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Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling and lip itchiness that was worsening. She had no SOB, no C/P, no dizziness, no generalized itching or rash. She has history of allergic reaction to unknown substance leading to ED visit. I advised she go to ED for eval, a friend accompanied her, she did not feel ambulance was necessary.I called report to the ED Addendum on 1/1/2021: When I called, she said that one week later she had a similar reaction of lip swelling to another area of lips.
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| 46 | 2021-01-10 | eye swelling |
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci...
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01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
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| 46 | 2021-01-10 | dry mouth |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | loss of taste, loss of smell |
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain...
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Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
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| 46 | 2021-01-11 | ear pain |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | dry mouth | Body aches, chills, feverish feeling, mild shortness of breath, dry mouth |
| 46 | 2021-01-11 | mouth tingling |
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is...
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Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
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| 46 | 2021-01-11 | swollen tongue |
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach...
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Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
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| 46 | 2021-01-11 | oropharyngeal discomfort, mouth tingling | rash and itching around neck and upper chest, tongue feeling funny and tickle in my throat |
| 46 | 2021-01-12 | swelling of eyelid |
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slight...
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01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
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| 46 | 2021-01-12 | mouth tingling, swollen tongue |
After waiting in the waiting area for about 20 minutes following the vaccination, I left to return t...
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After waiting in the waiting area for about 20 minutes following the vaccination, I left to return to my car and go home. While walking through the hospital, I started to feel weird - almost light headed and fuzzy. By the time I got to the hospital entrance, my tongue had started to tingle and swell (I don't know that it ACTUALLY swelled, but that's how it felt) and I was concerned about losing the ability to breath. I started going back to the vaccination site, but the feeling started to subside. After about another 15 minutes, the feeling was gone. I did NOT report this to the vaccination site and instead just proceeded home.
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| 46 | 2021-01-12 | ringing in ears |
Developed tinnitus the day I got first Pfizer COVID vaccine. Never had any known tinnitus nor hearin...
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Developed tinnitus the day I got first Pfizer COVID vaccine. Never had any known tinnitus nor hearing concerns nor hearing problems prior. Tinnitus is bilateral has been constant and continues now day 9 post vaccine. Did a hearing test that is showing mild sensorineural hearing loss in the high frequencies
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| 46 | 2021-01-12 | ear pain |
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ...
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Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
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| 46 | 2021-01-12 | pain in jaw, hearing loss |
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin...
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Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
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| 46 | 2021-01-12 | ringing in ears | Systemic: dizziness, tinnitus, blood pressure 220/112 |
| 46 | 2021-01-12 | vision blurred |
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha...
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The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
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| 46 | 2021-01-12 | ringing in ears, deafness unilateral |
Woke up on 26th and couldn't hear anything out of left ear - like I was deaf in that ear - Buzzing a...
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Woke up on 26th and couldn't hear anything out of left ear - like I was deaf in that ear - Buzzing and constant titch in it. Went to ER and they first thought I had wax in it - couldn't hear after they flushed it with warm water. Didn't change anything . Did a brain MRI - and that was negative. Did some bloodwork - and it all came back okay. After all that - 6 hrs there: Prednisone - 60 mg a day for 10 days. After 24 hours of taking that my hearing was back - there was huge improvement. I Still have very loud ringing in my ear. Constant buzz in my ear. Had a hearing test to test and it looks pretty good. Going back in three months for hearing test.
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| 46 | 2021-01-13 | mouth tingling, ear discomfort |
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or poppin...
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Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen. The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided. Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy. Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm. Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
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| 46 | 2021-01-13 | vision blurred |
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,...
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Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
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| 46 | 2021-01-13 | taste impairment, smell distorsion |
sensed/tasted metallic; sensed/tasted metallic; This is a spontaneous report from a contactable cons...
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sensed/tasted metallic; sensed/tasted metallic; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EK9231) solution for injection in the left arm on 05Jan2021 at 16:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included hypertensive. Concomitant medications included metoprolol; ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc (AIRBORNE); and an unspecified diuretic. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 at 16:30, the patient experienced sensed/tasted metallic. The patient stated, "Immediately after the vaccine was injected, I sensed/tasted metallic. It has been four days since the injection and I still have the metallic taste." No treatment was provided for the event sensed/tasted metallic. The outcome of the event sensed/tasted metallic was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 46 | 2021-01-14 | mouth tingling |
A few minutes after receiving the vaccine patient developed tingling in all four extremities and st...
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A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
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| 46 | 2021-01-14 | mouth tingling |
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t...
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A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
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| 46 | 2021-01-14 | dry mouth, taste impairment, thirst |
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta...
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Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
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| 46 | 2021-01-14 | tongue discomfort |
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ...
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I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
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| 46 | 2021-01-14 | dry mouth | Lightheaded, dizzy, nausea, dry mouth, shortness of breath |
| 46 | 2021-01-14 | ear pain |
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ...
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arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
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| 46 | 2021-01-15 | mouth tingling, swollen tongue, lip swelling |
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo...
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Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
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| 46 | 2021-01-17 | loss of smell, loss of taste | 1/6/21 Cough, loss of taste and smell, congestion, runny nose, HA, fatigue, wheesing |
| 46 | 2021-01-17 | mouth numbness |
I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ...
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I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more. I had sl elevated BP 148/86 and pulse ox at 97% and HR 95. Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.
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| 46 | 2021-01-17 | lip itchiness, mouth tingling, lip swelling |
Pt presented to ED with allergic reaction after receiving Pfizer Covid vaccine itching, swelling in ...
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Pt presented to ED with allergic reaction after receiving Pfizer Covid vaccine itching, swelling in right upper lips, slight tingle Patient received the Pfizer vaccine and developed right upper lips swelling plus pruritus within a span of approximately 45 minutes. After presenting to the ED, she was found to be hemodynamically stable with no further complaint in regards to pain, fever, nausea/vomiting, rash or other systemic responses. Airway appeared to be intact. Patient had a tryptase lab drawn (4ug/l which was within normal limits). Patient had a distant history of hives although the med/agency was unknown. No other signs of allergic reaction. Speaking in a clear voice. Maintaining good oxygen saturation. less likely anaphylaxis. Given 50 mg of Benadryl in triage. Pt Observed for 3 hours after the vaccine for progression of the swelling. Patient continued to do well and was sent home with follow up occupation health regarding recommendations regarding the second dose in 3 weeks. Given the limited nature of exam findings, mild form of vaccine reaction could not be ruled out. However, the cause of her symptoms could also be due to other factors including food (no detailed history on this).
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| 46 | 2021-01-17 | mouth numbness |
This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg...
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This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg and acetominopehn 500 mg 2 hours prior to vaccine. 15 min in I got wheezing, thorat tightness and tongue numbness. EMTs again called and again sats ok, BP ok and HR in 90s. Wheezing better with 4 inhalations of Albuterol HFA. They wouldn't give me any meds without sending me to ER, so I left and went home and took 50 mg Benadryl and another 2 sprays of albuterol at 4 hours post vaccine and did well.
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| 46 | 2021-01-18 | mouth numbness, taste impairment, mouth tingling |
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen...
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1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
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| 46 | 2021-01-18 | mouth tingling |
I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here...
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I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here and there. Noticed my tongue felt swollen and tried to swallow some water and had difficulty, realized I was having a little anaphalxsis reaction. It started approximately it 12pm, maybe earlier, I was busy.
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| 46 | 2021-01-18 | lip swelling |
Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon...
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Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
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| 46 | 2021-01-19 | ear discomfort, mouth itchiness |
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ...
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A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
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| 46 | 2021-01-19 | ear discomfort |
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min...
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Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
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| 46 | 2021-01-19 | pain in jaw, ear pain |
Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into e...
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Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
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| 46 | 2021-01-20 | mouth numbness |
numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth a...
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numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth and right cheek, and Headache. all except fro headache Resolved by 0630. Numbness lower lip and chin started at 0831 1/21/21, headache persists. No muscular deviation.
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| 46 | 2021-01-21 | sensitivity to light |
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe...
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Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
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| 46 | 2021-01-21 | ear pain |
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side ...
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On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side wit ear and base of neck was tender and painful to touch. Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea. These have provided short periods of relief.
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| 46 | 2021-01-22 | thirst, dry mouth |
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right ...
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Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
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| 46 | 2021-01-23 | taste impairment, loss of taste |
Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia;...
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Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia; chills; nausea; loss of taste; malaise (almost exactly 12-hrs post injection and stopped 24-hrs post injection (almost to the exact timing from inj)). Please note: Lot number could be: ER4176 or EU4176 (unable to clearly ready handwriting on the card)
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| 46 | 2021-01-24 | mouth numbness |
Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some o...
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Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some of spilled down my face and I thought I just had a fat lip. 27th, I went to work and went to lunch at noon, I went to eat food and I noticed that my mouth -right side was numb. I thought something might be wrong and someone told me that my right side of my face looked slack. Saw on Dec 28, Dr. - had already scheduled an appt for follow up for diabetes - and I told her about my symptoms and she looked at my face and had me smile and crinkle my face. She sent me to my doctor downstairs (she had the nurse call downstairs and told them I needed to be seen that day). I went downstairs and I saw my doctor and my doctor scheduled an MRI on 28th at 7 PM and also ordered for me to take Prednisone and Valtrex. MRI result came back fine. I responded well to both of these meds - I started to get muscle control back into my face. It shot my sugar numbers up but solved the other problem in about 15 days I could shut my eyes without delay and I feel like I have muscle control in my face. January 22, I got the second dose and so far I don't notice anything different.
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| 46 | 2021-01-24 | eye irritation, eye pain |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-24 | mouth tingling, visual impairment |
Individual started to feel her heart begin to race. she said she felt a little light-headed and her...
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Individual started to feel her heart begin to race. she said she felt a little light-headed and her vision was "off". She had a headache coming to the clinic which she had taken excedrine for prior to arriving. We took her blood pressure about 10 minutes after vaccination and it was 150/88 HR 130. We moved her into a private room to monitor and attempt to relax her. continued BP monitoring every 5-10 minutes- 148/92 147, 160/90 155. She stated that her left lip felt tingly so at that time we decided to call 911.
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| 46 | 2021-01-24 | swelling of eyelid |
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank...
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Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
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| 46 | 2021-01-24 | eye discomfort |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-25 | mouth tingling |
Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this findi...
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Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this finding at today's visit. She said she just took a Benadryl when she got home following her first dose. I did question if she has had anaphylaxis in the past to any meds, etc, and she said no, but reported having allergic symptoms with an antibiotic. No other allergic history to vaccines, meds, etc. Patient wanted to continue with second dose of vaccine today. Vaccinated at 1615. Patient reported tongue tingling at 1640. 25mg PO Benadryl given at 1640. Patient left the clinic at 1700 stating that she felt ok to leave. She had Benadryl at home and knew who to call if symptoms worsened. Writer called the patient back on 1/26/2021 at 1100. Patient stated that at 1900 last night (1/25/2021) she had to go to the Emergency room and received 2 doses of Epinephrine. She then had to stay the night to be observed. Patient stated that she was being discharged today.
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| 46 | 2021-01-25 | toothache, pain in jaw, eye pain, ear pain |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | taste impairment |
Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, be...
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Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, before the shot she had no sore throat or Cough
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| 46 | 2021-01-26 | ringing in ears |
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i...
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Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
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| 46 | 2021-01-26 | swelling of eyelid |
right side under her eye was swollen; right side of face was swollen; This is a spontaneous report f...
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right side under her eye was swollen; right side of face was swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient reported she had the first shot on yesterday (12Jan2021); it was given by a nurse at the hospital where she works. Last night, she noticed on the same side that she got shot, her right side under her eye was swollen and the right side of her face was swollen too. She wanted to know what to do and wanted to know if they were side effects. No therapeutics measures were done in response to the events. At the time of last observation, events' outcome was not recovered. Information about Lot/Batch number is requested.
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| 46 | 2021-01-26 | mouth tingling, mouth numbness |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-26 | tunnel vision |
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine...
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tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-27 | eye strain, bloodshot eyes |
About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feel...
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About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feeling of not feeling well. I ate some food and drank some ginger tea and it helped a little but after another hour I felt terrible with the same symptoms. They lasted for three days where I needed to go to bed by 6:00 PM or as soon as I could each night. On Sunday, January 24, 2021, 12 days after receiving the vaccine my eyes turned red and tired. I took my Claritin that I take if my allergies bother me and did some eye drops but it did not go away. I have had read eyes for five days now, it's more of a strained eye look and no other symptoms such as discharge, just a red eye on the whites of my eye. I do not know if this is related to the vaccine, but my allergies meds are not working, eyedrops are not working, and I had a COVID Lab test Monday 1/25/21 it was negative and a COVID Rapid test today 1/28/21 and it was negative.
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| 46 | 2021-01-27 | burning mouth syndrome | High Fever bones hurt sores under tongue and inside throat Weak |
| 46 | 2021-01-28 | visual impairment |
I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway ...
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I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway at the hospital (I am a physician) when all of a sudden I experienced vertigo (I was not dizzy, but I felt my vision shift to the left). I fell down, landing against 2 crash carts that were in the hallway. I did not lose consciousness. I had persistent dizziness and nausea for at least 10 days afterwards.
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| 46 | 2021-01-28 | ear pain |
Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated...
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Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
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| 46 | 2021-01-29 | pain in jaw, dry mouth, eye twitching |
4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of he...
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4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of her left eyelid, some left-sided jaw pain, a cotton mouth sensation, and migratory left-sided facial paresthesias described as a tingling sensation that could involve the eyelid, nostril, scalp, cheek, or forehead. These sensory symptoms feels somewhat like a Christmas tree with lights going on and off in different spots but always restricted to the left side of her face. In addition she experience a mild headache but without associated scotoma, nausea, vomiting, or vertigo. Upon looking in the mirror she thought that perhaps there is some slight facial asymmetry on the left side. In addition she reports feeling that her neck is weak on the left side and that she has to support her head in order to keep it from flopping further to the left. The symptoms have been also associated with some pain in the left arm which has since improved as well as discomfort and achy sensation involving her left leg extending from the hip laterally down to the level of the knee. She was evaluated the next day by a neurologist. Her neurological examination demonstrates some subjective decrease in sensation involving the left V1 and V2 distribution but is otherwise normal. Difficult to know to what extent the prior Botox injections could be contributing to her worsening left-sided neck weakness. We are aware that the vaccine does induce a inflammatory cytokine response and it is conceivable that this is contributing to some of her symptoms. MRI was obtained to exclude any underlying CNS pathology that could be conceivably exacerbated in the setting of an inflammatory micro environment induced by the vaccine. There was no clear evidence of a new CNS lesion based upon the examination.
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| 46 | 2021-01-30 | eye itchiness |
The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 m...
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The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 mg at 6 pm and again at about 2 am as itching intense and disrupting sleep (as did chills and myalgia.)
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| 46 | 2021-01-31 | lip swelling |
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary nod...
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mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site. Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
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| 46 | 2021-02-02 | lip swelling | About 3 hours after the shot my lower lip started to swell. It lasted about 24 hours. |
| 46 | 2021-02-02 | ringing in ears |
sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from ...
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sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 46 | 2021-02-03 | mouth numbness |
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr...
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Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-03 | taste impairment, eye itchiness, lacrimation increased | Metallic taste, eyes watering, feeling jittery, eyes itching, needs to take deep breathe |
| 46 | 2021-02-03 | eye pain |
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te...
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Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
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| 46 | 2021-02-04 | eye swelling, eye itchiness |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-06 | eye pain, bloodshot eyes |
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch...
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On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
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| 46 | 2021-02-07 | swollen tongue |
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch...
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Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
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| 46 | 2021-02-07 | oropharyngeal discomfort |
When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt...
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When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt like my right side of my throat was sweet and then my asthma kicked in , I used my inhaler and I few hours all my symptoms went away.
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| 46 | 2021-02-08 | vision blurred |
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg s...
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0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl, 1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
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| 46 | 2021-02-08 | ear swelling |
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th...
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7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
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| 46 | 2021-02-08 | swollen tongue |
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w...
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One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
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| 46 | 2021-02-08 | burning mouth syndrome, taste impairment | See page 1. (Box 9). |
| 46 | 2021-02-08 | swollen tongue, mouth tingling, taste impairment |
Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is...
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Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.
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| 46 | 2021-02-08 | lip swelling |
Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadr...
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Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
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| 46 | 2021-02-09 | eye pain |
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain ove...
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Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
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| 46 | 2021-02-09 | swelling of eyelid, eye pain |
Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, ...
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Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, mainly my neck, stomach and back Day 10 Left eye is swollen and pain on eyelid and behind eye lid
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| 46 | 2021-02-09 | mouth numbness |
Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was exp...
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Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was experiencing a headache, tongue and right arm numbness. After MD assessed patient (and patient relayed this was the same reaction she had with the first vaccine), MD kept her in the observation area for 30 minutes as the symptoms subsided. Patient was released when all symptoms were gone.
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| 46 | 2021-02-10 | loss of taste, loss of smell |
The day before the vaccination (12/14/20) I was exposed to COVID. I even filed an incident report at...
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The day before the vaccination (12/14/20) I was exposed to COVID. I even filed an incident report at work but they told me to receive the vaccine the next day (12/15/2020). I asked for a test before the vaccine and I was refused. The day after the vaccine (12/16/2020) I started with muscle ached and soreness. Talked to employee health who told me it was expected from the vaccine. I asked to be tested again and they told me no need to, it was from the vaccine. On the 3rd day after the vaccine, I stated with elevated temperature (99.9F and 100.1F) and also fatigue and not feeling well. Communicated with Employee health and once again, was refused the test. On the 4th day I started with cold symptoms and a cough - reported to employee health and once again, no test. All this time I have been working with patients at the hospital, I was not away from my duties. On day 7 I lost my sense of taste and smell and finally on day 8th t(12/23) they tested me after I insisted a lot. My result came back positive. I still had fever for another 3 days after the positive result and the sense of smell/taste and the fatigue were present for another 2 or 3 weeks.
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| 46 | 2021-02-11 | mouth tingling | Flushed, tingling in mouth |
| 46 | 2021-02-14 | eye swelling, visual impairment |
Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like loo...
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Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
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| 46 | 2021-02-15 | mouth numbness |
Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13...
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Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13/2021 half of face was unresponsive and droopy. Talked to my doctor on call and she recommended I be seen at urgent care immediately for evaluation. Was seen at Urgent Care on 2/13/2021 and it was determined I had Bell?s palsy as a side effect of the COVID-19 vaccine. They still recommended to get my second vaccine as scheduled on 2/17/2021.
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| 46 | 2021-02-16 | toothache |
Fillings in my teeth on the left side of mouth began to hurt after shot. Pain continued for over 2 h...
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Fillings in my teeth on the left side of mouth began to hurt after shot. Pain continued for over 2 hours post shot and while completing this form.
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| 46 | 2021-02-16 | swollen tongue, lip swelling |
This happened the first shot also but I thought it was just me being anxious. Immediately following...
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This happened the first shot also but I thought it was just me being anxious. Immediately following my roof of my mouth felt big. Then my tongue and lips felt the tiniest bit swollen. I could breath fine. Then my face (especially my left side) was a bit numb. The same thing happened to my friend but we couldn?t find anything online about our symptoms. I ended up telling the nurse at the front and they told me to take Benadryl and call 911 if scared. They made sure I wasn?t going to be home alone. I felt better within a 1/2 hour of taking the meds. My throat feels a little sore right now along with my arm.
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| 46 | 2021-02-16 | mouth tingling |
Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department repo...
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Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department reporting paresthesia in lips and in feet.
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| 46 | 2021-02-17 | taste impairment |
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl...
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tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
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| 46 | 2021-02-18 | mouth tingling |
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. ...
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Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
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| 46 | 2021-02-18 | lip swelling, dry mouth, mouth tingling, feeling of choking, swollen tongue |
CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingl...
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CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingling in her mouth and tongue/lip swelling and dry mouth. Denies difficulty swallowing) Assessment/Plan: DIAGNOSIS at time of disposition: 1. Allergic reaction, initial encounter Symptoms: Patient had second dose of COVID 19 vaccine today at 1230 p.m. She states at around 530 - 6 p.m. she started coughing and felt like that was a hair caught in the back of her throat, states throat is tingling and looked in the mirror and states her tongue is swollen. Feels that her heart rate is abnormal, but states it could relate to anxiety. COVID vaccine clearance needed if future booster needed. Informed patient to follow up with PCP if needed after ED visit. HISTORY OF PRESENT ILLNESS: The patient got her 2nd dose of COVID vaccine today at noon. At 5 she started feeling a bit of a tickle and scratchiness of her throat and her mouth felt very dry. She was concerned about allergic reaction. No shortness of breath chest pain rash itching hives or any other concerns. She has not taken any Benadryl. The patient is in no distress. Symptoms been going on for 3 hours. This could be a very mild allergic reaction. Therefore I am giving her 50 mg of oral Benadryl. Given the symptoms been going on for 3 hours and I do not see any angioedema I am comfortable letting her go home at this point in time. I do not think steroids would be beneficial. She will return here if worsening and I instructed her to use Benadryl 50 mg every 4-6 hours if needed. BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 171/98, HTN (>/=140/90), recommend follow up with PCP within 1 month.
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| 46 | 2021-02-18 | swollen tongue |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-19 | visual impairment |
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ...
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24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
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| 46 | 2021-02-22 | lip swelling, eye swelling | Heaviness in chest. Swelling on face , eyes and lips |
| 46 | 2021-02-23 | feeling of choking, mouth tingling |
Patient complained of tingling of lips & tongue, tingling of throat w/ cough, tight breathing. Clea...
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Patient complained of tingling of lips & tongue, tingling of throat w/ cough, tight breathing. Cleared by EMS after supportive care.
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| 46 | 2021-02-23 | mouth numbness |
on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Du...
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on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Due to the fact I have no chronic conditions, live a pretty healthy life, I was told by EMS and various ID doctors it was most likely from the vaccine. Today is day 21 and I still have no movement in face
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| 46 | 2021-02-24 | mouth numbness |
Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptom...
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Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.
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| 46 | 2021-02-25 | taste impairment | Metallic taste in mouth... slightly itchy throat which went away but the metal taste did not |
| 46 | 2021-02-25 | mouth numbness | Numbness in tongue and hands |
| 46 | 2021-02-25 | swollen tongue, lip swelling, mouth discomfort | Swollen lips, tongue and mild burning sensation in the lips and tongue. |
| 46 | 2021-03-01 | eye twitching |
The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal s...
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The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
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| 46 | 2021-03-02 | swelling of eyelid |
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head...
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On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
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| 46 | 2021-03-02 | sensitivity to light, eye pain |
body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight ...
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body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.
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| 46 | 2021-03-03 | mouth tingling |
Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and ...
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Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and wheezing yesterday, she has a history of asthma. The chest tightness and wheezing increased after her vaccine. She also noted tingling to her lips and dizziness. She had no shortness of breath, cough, palpitations or chest pain. No angioedema, rash or pruritis. She was in no acute distress. She was talking in complete sentences and drinking water without any issues. Her lungs were clear through out with no bronchospasm, her heart rate was regular. BP 160/100, HR 66, RR 22, O2 99% on room air. I spoke with the RN at ICC who accepted patient to be seen at the ICC for further evaluation and monitoring. Patient declined ambulance transfer and felt comfortable enough to drive her self to the ICC. She was monitored at the vaccine clinic for 35 minutes after receiving her vaccine and left in stable condition. Her sister was notified.
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| 46 | 2021-03-03 | mouth numbness, mouth tingling | Tip of tongue and upper and lower lip fell numb and tingly. Alleviated with Benadryl 50mg orally. |
| 46 | 2021-03-03 | burning mouth syndrome | Tongue soreness and anxiety, resolved without medication intervention |
| 46 | 2021-03-04 | mouth tingling | Lips and tongue felt tingly and raw |
| 46 | 2021-03-04 | mouth tingling |
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) s...
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Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel " a tingly sensation in my tongue" and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling, nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl. Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
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| 46 | 2021-03-05 | eye itchiness, swollen tongue |
After waiting the 15 minute observation period, I left. While driving home my eyes started itching a...
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After waiting the 15 minute observation period, I left. While driving home my eyes started itching and my face felt strange. When I got home I looked in the mirror ni didn?t see a rash or any swelling in my face but then felt my tongue was swollen. I took a Benadryl and called the on call doctor from primary care physicians office and was directed to go to the ER since it was a potentially life threatening reaction.
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| 46 | 2021-03-05 | eye pain, vision blurred | Headache, blurry vision, heart palpitations, feeling off, eyes sore, eyes hurt, |
| 46 | 2021-03-06 | taste impairment, lip swelling |
reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, t...
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reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, tachycardia and high blood pressure I was given benadryl and when symptoms did not improve was taken to ER and given Decadron at 4:42pm then Famotidine and Sodium Chloride 0.9%
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| 46 | 2021-03-07 | swollen tongue, tongue itchiness |
Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received...
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Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received shot at 10:39 am showed signs at 10:42am
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| 46 | 2021-03-07 | oropharyngeal discomfort |
Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM...
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Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
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| 46 | 2021-03-08 | mouth itchiness |
2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light hea...
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2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light headed, tingly hands and face. On 3/6/21, woke up with swelling, hot, red, itchy swelling at injection site. On 3/8/21, patches of rash that would come and go, face, mouth, and throat itchy. Hand and arms tingly and felt like I was going to pass out. Later that day, had my 1st migraine in my life. 3/9/21-Today, hands, arms, face, mouth, and throat itchy. Finger tips went numb and ring finger on left hand showed signs of bruising (I didnt hurt it that I know of). By the time I got to urgent care, finger no longer bruised color. Light headed, felt like going to pass out again.
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| 46 | 2021-03-08 | swollen tongue |
20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized ting...
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20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized tingling in her hands and feet and felt like her tongue was a bit swollen. Stated she felt "funny". Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
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| 46 | 2021-03-08 | ringing in ears |
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER...
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ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER. VASOVAGAL LIKELY.
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| 46 | 2021-03-09 | mouth tingling |
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ...
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1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
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| 46 | 2021-03-09 | deafness unilateral | Complete left ear hearing loss two weeks after vaccine #1 |
| 46 | 2021-03-09 | swollen tongue |
Pt reported tongue swelling 92% 02 RA, throat itches, given Zyrtec 10mg, PO @1400. pt given Benadry...
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Pt reported tongue swelling 92% 02 RA, throat itches, given Zyrtec 10mg, PO @1400. pt given Benadryl 50mg IM, 14:12 02 93% RA, placed o2 2L via nasal canula, 14:21 Pt reports feeling better. BP 128/71, HR 67 02 99% RA. Pt dc home stable. Pt has a partner with her to drive.
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| 46 | 2021-03-09 | dry mouth, lip swelling, swollen tongue |
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything...
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The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
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| 46 | 2021-03-13 | ear discomfort | Fever, chills, body aches, headaches, nasal congestion, runny nose, ear pressure. |
| 46 | 2021-03-14 | visual impairment |
3/11 to 313 - Flu like symptons...no fever. Chills, aches and severe fatique 3/14 to present day - V...
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3/11 to 313 - Flu like symptons...no fever. Chills, aches and severe fatique 3/14 to present day - Vertigo - non stop dizziness, foggie vision
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| 46 | 2021-03-14 | mouth tingling, oropharyngeal discomfort |
I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my...
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I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my teeth and lips. My throat felt full and I was coughing slightly. Within an hour and 10 minutes after the injection, I started to feel back to normal.
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| 46 | 2021-03-14 | mouth numbness, lip swelling |
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw...
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Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
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| 46 | 2021-03-15 | mouth tingling |
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ...
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25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
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| 46 | 2021-03-15 | swollen tongue |
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl...
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First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
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| 46 | 2021-03-16 | ear pain |
03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very...
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03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off. 03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed. 03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well. 03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued. 03/15/21 ear still sore some throat better than before went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
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| 46 | 2021-03-16 | mouth tingling |
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines...
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Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
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| 46 | 2021-03-16 | eye swelling, thirst |
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of t...
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I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
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| 46 | 2021-03-17 | swollen tongue |
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with sh...
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Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller. Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78 BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
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| 46 | 2021-03-18 | taste impairment | Metallic taste in mouth that does not go away. |
| 46 | 2021-03-18 | ear pain |
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la...
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On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
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| 46 | 2021-03-19 | mouth tingling |
This was the second dose. No immediate reactions after injection. Approximately 6 hours later, inter...
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This was the second dose. No immediate reactions after injection. Approximately 6 hours later, internal itching began throughout my entire body. I also had a slight tingling of the tongue and lips. Benadryl did not ease the itching or mouth tingling. The internal itching by the next day and increased doses of Benadryl still did not help. Intense itching by day 3 as well as fever of 99.5. Saw an online doc who prescribed Hydroxyzine for itching. It is now day 9 after the second vaccine. Itching internally has worsened. Still have tongue and lip tingling as well. I saw another online doc to tell them symptoms have continued and have worsened a bit and that I have been 24 hours without the Hydroxyzine. The prescription ran out the day prior. Doctor prescribed more Hydroxyzine. This time around the Hydroxyzine does not seem to be as effective. While it helps a bit with me sleeping, the itching is still quite severe. The severe internal itching has been going on for 9 days and has affected my quality of life. The itching is nonstop and is happening in all parts of my body. No other antihistamine is effective and is able to be taken during the day except the Hydroxyzine which causes grogginess and has become less effective.
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| 46 | 2021-03-20 | tongue itchiness |
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vacc...
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1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
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| 46 | 2021-03-21 | tongue disorder |
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv...
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10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
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| 46 | 2021-03-21 | deafness, hearing loss, ear discomfort |
Hearing loss. Feels like pressure in ears. Like they need to pop. Noticed I can?t hear as well when ...
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Hearing loss. Feels like pressure in ears. Like they need to pop. Noticed I can?t hear as well when in the car listening to radio.
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| 46 | 2021-03-22 | eye movement disorder | Bell's palsy symptoms. Droopy eye (right) and tingling in the ears. |
| 46 | 2021-03-22 | eye swelling, swelling around the eyes | Progressive over 3 days: Throat irritation, throat burning, difficulty breathing, puffy/swollen eye. |
| 46 | 2021-03-23 | ringing in ears |
9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed do...
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9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed down and I did get the second vaccine. 9 days after that, my ears started ringing again, this time the volume much higher. It has been 3 weeks today and it is still ringing so loudly. It is interrupting sleep, causing anxiety and making day to day activities difficult. It is ringing all the time and is unrelenting.
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| 46 | 2021-03-23 | oropharyngeal discomfort |
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throa...
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About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room. Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related. My arm hurts quite a bit today but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
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| 46 | 2021-03-23 | lacrimation increased, bloodshot eyes, eye discomfort, eye pain |
Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both...
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Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-03-23 | taste disorder | Medicine taste on tongue that has been ongoing for the past 11 hours thus far |
| 46 | 2021-03-23 | mouth itchiness, mouth tingling |
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight...
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Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
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| 46 | 2021-03-24 | eye strain, oropharyngeal discomfort, taste impairment, dry mouth |
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon a...
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I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ). This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
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| 46 | 2021-03-24 | mouth tingling, mouth itchiness, swollen tongue |
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes...
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Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
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| 46 | 2021-03-24 | mouth discomfort |
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu...
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congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
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| 46 | 2021-03-25 | swollen tongue, taste impairment |
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi...
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Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
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| 46 | 2021-03-25 | taste impairment | Metal taste lightheaded and nausea |
| 46 | 2021-03-25 | ringing in ears | Tinnitus |
| 46 | 2021-03-25 | swollen tongue, oropharyngeal discomfort | Tongue swelling and posterior throat discomfort GIven 25 mg PO Benadryl with resolution |
| 46 | 2021-03-26 | eye swelling |
On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm...
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On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm/breast area on the left side .By the afternoon all swelling was gone except under the arm. It is uncomfortable to put my arm close to my body and to lay on that side today. It is still sore and swollen today.
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| 46 | 2021-03-26 | mouth tingling | tongue tingling, observed an extra 30 minutes, denied Benadryl |
| 46 | 2021-03-27 | mouth discomfort |
For about a week after the shot, I felt like my mouth was filled with cat fur. Not cotton mouth, not...
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For about a week after the shot, I felt like my mouth was filled with cat fur. Not cotton mouth, not thrush, but specifically cat fur. It would disappate if I drank a lot of water, but would come back in a few hours. Lasted about a week.
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| 46 | 2021-03-27 | mouth tingling |
Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, ...
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Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, still tingling sensation around the mouth, and fatigue. The fatigue never went away.
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| 46 | 2021-04-01 | mouth swelling, ear itchiness, lacrimation increased, lip swelling |
Excessive yawning and watering eyes started immediately, but otherwise fine. 30 mins after vaccine ...
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Excessive yawning and watering eyes started immediately, but otherwise fine. 30 mins after vaccine started with ?tickle in throat? and coughing. Within minutes wheezing and immediately left for urgent care. Wheezing was increasingly pronounced and couldn?t breathe. Itchy ears and throat, swelling of mouth/lips and felt throat closing. Husband pulled over to administer epi shot (used inhaler multiple times prior with no relief) At urgent care received steroids and benedryl through IV and oxygen. Rushed immediately to hospital by ambulance where I received additional meds and albuterol breathing treatment
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| 46 | 2021-04-07 | mouth tingling, swollen tongue |
atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventuall...
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atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventually sensation of swelling in her throat within 60 minutes. There were no other secondary systemic/organs affected apart from mild transient hypertension. Given the strong concern for subjective airway compromise, I directed the administration of epi which the patient said she felt her throat relax after adminstration. 911 was called and patient was transported to ED.
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| 46 | 2021-04-07 | swollen tongue |
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voic...
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post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again. At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
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| 46 | 2021-04-12 | swollen tongue |
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla...
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skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-14 | mouth tingling, tongue itchiness, swollen tongue, mouth numbness |
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face...
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Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well. Symptoms lasted several hours. It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
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| 46 | 2021-04-15 | vision blurred |
Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my ...
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Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my chest was tight, so it was hard to catch my breath. My whole face and ears turned red and i was itchy on my arms. 2 doses of Benadryl made the allergic reaction ease. I was tired for the next two weeks, and then started having heart palpitations regularly. Went to ER was diagnosed with Tachycardia, Hyperkalemia, Hypomagnesemia, and Hypocalcemiaand. Corrected with intravenous drugs and overnight stay in the hospital. Slowing feeling some better, but struggling with inflammation and being exhausted. Felt 100% great before getting this vaccine. Advised by doctors not to get second shot and did not get it.
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| 46 | 2021-04-20 | loss of taste |
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an...
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Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
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| 46 | 2021-04-21 | swollen tongue, eye swelling, mouth numbness, mouth swelling |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
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| 46 | 2021-04-28 | extreme sound sensitivity |
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi...
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Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-05-10 | lip swelling |
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;...
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had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
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| 47 | 2021-01-05 | lip swelling |
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain...
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Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
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| 47 | 2021-01-05 | eye pain |
Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous re...
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Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. The patient stated, "fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst". The patient received treatment. The outcome of the events was not recovered.
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| 47 | 2021-01-06 | vision blurred | Mild throat swell, nausea, blurred vision |
| 47 | 2021-01-07 | mouth tingling, mouth tingling |
12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling li...
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12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling like throat was swelling. Patient was taken to ED via wheelchair. Monitoring and BP @7:40 135/83 HR 72 Resp. 18. Under oBS at hospital, not admitted. *Initial dose reported symptoms of feeling sick with dose 1 but not to extent of second dose
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| 47 | 2021-01-07 | tongue discomfort, swollen tongue |
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan...
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Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | tongue itchiness |
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over b...
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Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.
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| 47 | 2021-01-07 | dry throat |
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside m...
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Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.
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| 47 | 2021-01-07 | mouth tingling |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | swollen tongue |
tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nur...
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tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nurse reported that she received BNT162B2 (lot EL0140) 1st dose intramuscular at Left Deltoid on 28Dec2020 9:38 for COVID-19 vaccination. Medical history was none. Concomitant drug was not provided. The patient reported in the evening on 28Dec2020, she noticed her tongue swelling. She started to notice her tongue swelling shortly after dinner, probably around 6:30-7 in the evening. She was a little bit on pins and needles regarding this reaction. It happened quite a few hours later after receiving the vaccine. She was thinking should she go to urgent care or emergency room or not. Her tongue was still swollen but it seemed like over the week, the swelling had gotten better. However, the swelling came back. So really overall, the swelling hasn't gotten much better. She hasn't been drooling due to the swelling. She hasn't had issues with eating, drinking, swallowing or breathing. She just had ridges around her tongue. Her tongue felt a little bit heavy. The question she had was how long was this going to take before the swelling went away and was it safe her to take the booster shot (second vaccine)? The swelling was still persisting. The outcome of the event was not resolved.
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| 47 | 2021-01-08 | taste disorder |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-08 | dry mouth, swollen tongue, thirst |
Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and...
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Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and throat started to swell. 50 mg of Benadryl was given. Started to feel better but 45 minutes later swelling started back up. Dryness in mouth still there and water couldn?t quench my thirst. Escorted to Emergency department. Epinephrine shot given 40mg of prednisone, 20 mg of Pepcid and 10 mg of Zyrtec given. Given another 20mg of prednisone, 10 mg of Pepcid and 10 mg of Zyrtec 1.5 hours later. Release after 4.5 hours. Given 3 days of medicine previously given. Swelling started back up 6 hours later so I took 50 mg of Benadryl. Swelling continued every 6-8 hours. Mouth was still really dry but as long as I drank 100 oz of water a day I was ok. Tuesday I had a small fever and very achy. Went to doctor and he prescribed 20 mg of prednisone twice daily tapering off for 11 days, 10 mg of Pepcid and Zyrtec twice daily for 11 more days. Finished my medicine Saturday January 2nd. I have been feeling better but still have swelling occasionally.
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| 47 | 2021-01-10 | swollen tongue |
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ...
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3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
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| 47 | 2021-01-10 | mouth numbness, tongue itchiness |
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to...
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? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
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| 47 | 2021-01-10 | taste disorder |
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notifie...
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At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notified who shows up immediately and evaluates, BP150/80mmhg Pulse 72/minute, Breaths 18/minute, afebrile, Communicative and alert in time place and space, not complications, is placed oxygen by nasal cannula at 3lt/min at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding
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| 47 | 2021-01-10 | taste impairment |
Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to s...
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Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to sleep after 2 Aleve.
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| 47 | 2021-01-10 | oropharyngeal discomfort |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | mouth tingling |
Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal ...
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Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal sensation in the back of my tongue. This lasted for about 20-25 minutes and then mostly resolved. I was monitored by the paramedics. I had normal vitals at the time of evaluation which was soon after notifying staff. After the 1st injection I had a similar episode, but I thought it was anxiety related.
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| 47 | 2021-01-11 | taste disorder |
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notifi...
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At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notified who shows up immediately and evaluates, BP 150/50mmhg, Pulse 71/minute, Breaths 18/minute, afebrile, Communicate and alert in time, place and space, not complications, is placed oxygen by nasal cannula at 3lt/min, at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding.
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| 47 | 2021-01-11 | inability to speak |
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of...
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Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
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| 47 | 2021-01-11 | ringing in ears |
Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent ...
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Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as "for work." The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like "when you have water in your ear." It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like "if you have water in your ear." It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event "developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now." Outcome of the events "headache" and "fatigue and feeling run down" was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-11 | swelling of eyelid |
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a...
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tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
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| 47 | 2021-01-11 | toothache, swollen tongue |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-12 | taste impairment |
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra...
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Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
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| 47 | 2021-01-12 | lip swelling |
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down...
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approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
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| 47 | 2021-01-13 | extreme sound sensitivity, ringing in ears |
Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in lef...
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Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in left ear, severe sound sensitivity, headache, then myalgia, fatigue, brain fog and disorientation, low grade fever of 99.6. Was sent home from work. Had COVID-19 testing and was negative. Worked from home the next day and still had myalgia and then had gastric issues of nausea and diarrhea, low grade fever.
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| 47 | 2021-01-13 | feeling of choking, feeling of choking |
Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color....
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Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color. Voices s/s of reaction to previous dose (swollen tongue). Initial compliant begin @ 1248, entered observation @ 1242. Benadryl 25mg was given @ 1249. S/S, relieved around 1305. Voices no other s/s of distress. Cold compress also applied to help alleviate s/s. Denies SOB or trouble breathing. Voices allergies to Aspirin, Morphine, Phenergan, Erythromycin. Left observation @ 1310.
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| 47 | 2021-01-14 | mouth numbness, mouth tingling |
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No S...
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24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No SOB, no swelling. 4 days later lips tingling. 7-9 days later random numbness and tingling of tongue, r. cheek, lips....comes and goes. No rescue medication used. No follow up pursued by patient.
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| 47 | 2021-01-14 | smell distorsion |
Change is related to sense of smell. Sweet aromas are not the same, the perception of sweeter aroma...
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Change is related to sense of smell. Sweet aromas are not the same, the perception of sweeter aromas is altered.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) solution for injection, via an unspecified route of administration on left arm on 28Dec2020 12:30 at a single dose for COVID-19 immunization. The patient medical history included allergy to echinacea. The patient was not pregnant. Concomitant medications included vitamin b complex and glucosamine. The patient reported that a change was related to sense of smell. Sweet aromas were not the same, the perception of sweeter aromas was altered on 31Dec2020. No treatment was received. The patient underwent nasal swab and tested negative on 06Jan2021. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.
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| 47 | 2021-01-14 | lip swelling | Pt reports lip swelling starting roughly 18 hours post vaccine. |
| 47 | 2021-01-14 | dry throat |
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then i...
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Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-14 | mouth tingling, mouth numbness |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-16 | swelling of eyelid, lip swelling |
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m...
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I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
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| 47 | 2021-01-17 | lip swelling, vision blurred, lip itchiness |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-18 | bloodshot eyes, eye pain |
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi...
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Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
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| 47 | 2021-01-18 | ear swelling |
Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after in...
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Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after injection swelled. within a few hours unable to turn head without pain. From base of head to back was so sore and for 24 hours hard to turn head..
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| 47 | 2021-01-18 | taste impairment |
Metallic taste in mouth within minutes of injections, throat felt swollen at 40 minutes but both res...
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Metallic taste in mouth within minutes of injections, throat felt swollen at 40 minutes but both resolved without intervention. Diarrhea within 24 hours of shot. Runny nose that started 24 hours later and lasted for 24 hours.
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| 47 | 2021-01-18 | loss of taste, loss of smell |
Symptomatic with covid 12/22-started with just sinus congestion and fatigue. Progressed to fever, ch...
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Symptomatic with covid 12/22-started with just sinus congestion and fatigue. Progressed to fever, chills and body aches 12/25, coughing shortness of breath 12/26,loss of taste and smell 12/27
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| 47 | 2021-01-18 | eye pain |
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we...
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fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
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| 47 | 2021-01-19 | taste impairment, smell distorsion, taste disorder |
Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my...
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Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient). This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks. The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
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| 47 | 2021-01-19 | eye pain |
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra...
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Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
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| 47 | 2021-01-19 | mouth tingling |
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt h...
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Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
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| 47 | 2021-01-19 | mouth tingling | Tingle in tongue Fullness in throat |
| 47 | 2021-01-19 | lacrimation increased |
fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am ...
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fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am along with headache and constant watery eyes. Difficulty taking deep breaths due to muscle soreness in back and ribs
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| 47 | 2021-01-20 | dry mouth |
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f...
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10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
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| 47 | 2021-01-20 | mouth numbness |
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 1...
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Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea. Took acetaminophen 1000 mg at 2 am. Stomach issues subsided 7 am, 20 hours after vaccine. Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
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| 47 | 2021-01-20 | mouth numbness, mouth tingling |
Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, a...
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Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, and tongue feeling larger than usual and numb. Provider informed, provider assessment revealed no rash, no redness, no visible swelling of tongue, and patient reported an itch on right arm. Vitals 9:35 BP 126/70, HR 88, oxygen saturation 99% on RA, and respirations of 20/min. Vitals retaken at 9:40 BP 117/70, HR 75, oxygen saturation 98% on RA, and 20 breaths/min. Vitals retaken at 9:50 BP 115/71, HR 74, oxygen saturation 98% on RA< and 18 breaths/min. At 9:53 patient stated her throat is no longer itchy, and tongue no longer feels large.
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| 47 | 2021-01-22 | ear swelling, pain in jaw, ear pain |
Headache, muscle soreness within 30 minutes of leaving the site. Then within 2 hours body fatigue, n...
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Headache, muscle soreness within 30 minutes of leaving the site. Then within 2 hours body fatigue, neck pain, jaw pain and ear pain with swelling. Dr visit by Wed afternoon and meds to fight ear pain and swelling.
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| 47 | 2021-01-22 | mouth discomfort, oropharyngeal discomfort |
Patient reports thickness on roof of mouth and back of throat. NP notified and 25mg Benadryl PO give...
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Patient reports thickness on roof of mouth and back of throat. NP notified and 25mg Benadryl PO given with good effect
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| 47 | 2021-01-24 | swelling around the eyes, swelling of eyelid, bloodshot eyes, lacrimation increased |
Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight head...
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Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight headache
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| 47 | 2021-01-24 | bloodshot eyes, eye disorder, eye itchiness, eye swelling |
right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right E...
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right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right Eye being Red; mucus from throat, clear mucus; Right eye weeping; Right eye pink; She was super congested/she couldn't breathe through the nose; barely being able to sleep; Right eye itching/Left eye itching; red and swollen eyes/right eye swollen; itchy throat/itching of the throat/scratching in the throat; runny nose, clear mucous (post nasal drip); This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Left arm, via an unspecified route of administration on 07Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Sinus infection, Kidney stones, pink eye when she was a kid. The patient's concomitant medications were not reported. She reports the following side effects: itchy, red and swollen eyes, itchy throat, runny nose, clear mucous (post nasal drip). The patient experienced Right eye itching, red and swollen eyes/right eye swollen, Right eye pink on 08Jan2021 with outcome recovering, right eye shut on 09Jan2021 with outcome of received on 09Jan2021, itching throat, mucus from throat, clear mucus, Right eye weeping on 08Jan2021 with outcome of recovered/resolved with sequel on 11Jan2021, Left eye itching on 08Jan2021 with outcome of recovered on 09Jan2021, runny nose, clear mucous (post nasal drip) on 08Jan2021 with outcome of recovered on 11Jan2021, right eye red/ right Eye being Red on 09Jan2021 with outcome of recovered on 09Jan2021. The patient got her First shot on Thursday morning at 7:30AM, then on Friday night 08Jan2021 at 7 in the evening her right eye was itching and weeping, it felt like something was in the eye but there wasn't. The right eye was swelling as well on Friday. On Friday the itching of the throat started. She is also having scratchiness in the throat. Her eye is scratchy also. When she woke up Saturday 09Jan2021 she couldn't open the right eye, it was glued shut completely and red. When she was a kid, in the past she has had pink eye, and there was green stuff coming out the eye but this was not like previously. She had to pull the eye lids apart, maybe this is viral. With her throat, she has had sinus infection in the past before in which she couldn't breath out of the nose, but with this she is experiencing Mucus that is clear and thin from the throat. Her left eye itching started Friday night, but it was only slight itchiness and by Saturday the left eye was normal. She is purely doing this report to help, in case other people have this happen. Early today, she did use a Neti pot and it did help a little, she has had horrible sinus infections in the past but this is not it. In the past, once you get a sinus infection you are prone to getting them, thankfully she has not had one in a few years, she would get thick crap in the sinuses, in this case her eye was draining going into her nose, therefore making her have a runny nose, and she also had scratching in the throat. She is breathing clearly through the nose. Itching in the right eye was ongoing but less intense. Right Eye Swollen: She was looking at mirror hates looking at herself but the eyelid was back to normal, however the white part of eye is still swollen. Right eye being Shut: It is open now, that was a one day occurrence. Itching in the throat: She noticed that today at noon around 1 is when she last had it, it is 5% still there where she feels something. Mucus from Throat: She used the Neti pot a couple hours ago, at about 1:30 PM. Since then she has had some drainage but it is 95% better. Her Right Eye ball is still pink looking like as if she was hung over. The Left eyeball is white. Right Eye Weeping: She left work because her right eye was weeping so much, going into her nose, and she is running at work, she has glasses, goggles, face shield, and so she cant wipe the liquid. She came home and iced her eye which helped. Right Eye Pink: On Saturday the right eye was red. Right now it is pink, like an eye lash is in the eye. The right Eye being Red was only for Saturday, like sclerosis, it was red and swollen. The left eye was swollen, but it is better now from this morning. She was super congested on Friday (08Jan2021), barely being able to sleep, she couldn't breathe through the nose. Weird, she barely slept but it wasn't a sinus infection. She couldn't sleep because of nose running and the eye running then Saturday into Sunday she was able to sleep with eye running. The runny nose got better with the neti pot. She is schedule for the 2nd dose on 28Jan2021. The outcome of other events was unknown. Information on the lot/ batch number has been requested.
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| 47 | 2021-01-25 | eye pain, bloodshot eyes |
My left eye turned red. I went to the doctor on 12/21, 12/23 it was not better. I woke up in tears b...
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My left eye turned red. I went to the doctor on 12/21, 12/23 it was not better. I woke up in tears because it was so painful. I went to the doctor again, they said it looked like inflammation of the iris. On 12/26 is saw an eye doctor that said it was episquaritis. I had a follow up appointment on 01/11 with the eye doctor he found out I have nodular degeneration. I had a follow up on 01/25 and was referred to a cornea specialists. This all started post vaccine. I have not history of eye problems.
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| 47 | 2021-01-25 | swelling around the eyes, lip swelling |
mild puffiness under eyes and on lip, mild sore throat, beginning about an hour after the shot and c...
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mild puffiness under eyes and on lip, mild sore throat, beginning about an hour after the shot and continuing to this writing
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| 47 | 2021-01-27 | ringing in ears, ear pain, deafness |
Hearing loss in left ear. Not complete but high pitch sounds. Ear has been ringing since onset. Came...
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Hearing loss in left ear. Not complete but high pitch sounds. Ear has been ringing since onset. Came on abruptly while sleeping at 5 am. There was pain initially. I am not sure if it is related as this did not occur until 1 week after I had the vaccine. However, I thought it was worth mentioning as the vaccine is so new.
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| 47 | 2021-01-27 | ringing in ears, ear pain |
Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours...
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Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours after vaccine. Swollen and painful armpit node started 1 day after vaccine.
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| 47 | 2021-01-28 | visual impairment, vision blurred, eye strain |
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision;...
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Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.
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| 47 | 2021-01-28 | taste disorder, smell distorsion | Fever as high as 103, muscle aches, joint pain, nausea, change in smell and taste, headache, chills |
| 47 | 2021-01-28 | oropharyngeal discomfort, feeling of choking |
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat...
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Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
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| 47 | 2021-01-28 | ear discomfort |
ears have been burning; she checked her temperature and it is lower than normal, her temperature is ...
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ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
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| 47 | 2021-01-30 | eye swelling, mouth numbness, lip swelling |
On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed h...
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On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed hives on my back, shoulder, and torso. Continued to take Benadryl that night. The next morning, Monday I woke up with continued hives on my torso, back, additionally on my bikini line area, and lower back area. I called my doctor's emergency line, to which I was instructed to continue with Benadryl, if it became worse, seek immediate medical attention. Tuesday morning I woke up with both arms covered in hives from shoulder of wrists, some on my neck and lower chin, swollen upper lip which also felt numb. I sought medical attention from primary care physician, Tuesday morning, by the time I arrived, the hives were also on my legs.
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| 47 | 2021-01-31 | pain in jaw | Chest pain. Upper back pain, jaw pain, pain in opposite arm |
| 47 | 2021-02-01 | visual impairment |
1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to t...
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1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to the Nurse. She also reported that she had the same symptoms after receiving the first Pfizer vaccine. Vitals were taking and patient was monitored. Patient later starting vomiting in clinic. EMS was called and patient left via ambulance. Methodist ED contacted prior to the patient arriving.
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| 47 | 2021-02-01 | taste disorder, mouth swelling, mouth tingling, swollen tongue |
Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling...
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Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling of the tongue mouth. They had me wait the additional 15 mins. Did the pulse/ox. I was normal. Advised to take antihistamine, which I did when I got home. Felt better that day. On Friday, Jan. 29 I noticed a rash on my torso - stomach, back from bra line down to buttocks. I texted a pic to my friend who is a pediatrician. She said it looked pityriasis rosea. It doesn't itch. I also began having tingling on my tongue again. As of today, 2/2, I still have the rash and some tingling on the tongue. I've been taking a generic claritan in the morning and a benadryl in the afternoon and before bed. I also received a notice at work on Friday and a phone call from the county on Saturday that I may have been exposed to covid on Jan. 26. I have had none of the symptoms typical of covid. Just the rash and the tongue tingling. I called the number today. They advised I complete this form. I am getting a covid test tonight.
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| 47 | 2021-02-01 | mouth tingling |
Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tyl...
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Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tylenol to attempt to prevent fever. I immediately noticed that the medication felt stuck in my esophagus and it was hard to swallow them down. Being a nurse I began to monitor more closely my breathing. I was able to take air into my lungs easily. Next I noticed that my nose became very stuffy and was difficulty to breath through but my airway continued to seem ok and I was breathing without difficulty through my nose. By about 210pm I had noticed that my face felt strange. As another few minutes progress my entire face felt numb like when your dental lidocaine is wearing off. It was a very disturbing feeling. I never had difficulty breathing but the throat and nasal swelling lasted about 1 1/2 hours. The facial numbness lasted at least 4 hours and my nose and tongue still feel a little strange even at this moment. I stayed in the observation area for about 35 minutes just to make sure I was not going to lose my airway before leaving. I am a nurse and I didn't want to get sent to the ER for hours just to be given benadryl since my airway was ok so I didn't report it at the time of incident. I had preloaded with zyrtec, pepcid and ibuprofen the morning prior to injection to try and avoid reaction or side effects that others were reporting. I think if I had not had antihistamine in my system I would have had anaphylaxis for sure. I went straight home and took more antihistamine. Contacted my doctor so she knew of the symptoms. She told me to continue the antihistamines for a few days and to go to the ER if severe issue happened. This was a VERY VERY scary incident. For a little history: after my first vaccine I noticed itching on my chest but couldn't see any rash. About day 3-4 a rash appeared. I was unsure if this was vaccine related since it took 3 days to appear. It was cleared after a few days of steroid cream.
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| 47 | 2021-02-02 | vision blurred |
Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injecte...
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Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injected, and then complained she feels burning sensation in her throat. Denies difficlty of breathing, headache. Transported to ED and treated with Benadryl. Took Benadryl for 3 days. Headaches lasted about 1wk and took ibuprofen. Employee reported she had hives for 3 days after her 1st dose. Took Benadryl. This wasn't previously reported to us.
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| 47 | 2021-02-02 | visual impairment, vision blurred |
I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even se...
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I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even send a text message. I?ve had a headache since I got the last vaccine, dizzy, blurred or abstracted vision.
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| 47 | 2021-02-02 | pain in jaw, ear pain |
right side neck pain, pain behind right ear and jaw with constant headache and heaviness in right e...
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right side neck pain, pain behind right ear and jaw with constant headache and heaviness in right eye. Symptoms started suddenly 5 days after vaccination without any trauma or change in my daily routine and are still present at this time. Pain relieved by Nsaids for about 4 hours then symptoms return.
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| 47 | 2021-02-03 | vision blurred |
Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai...
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Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
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| 47 | 2021-02-03 | eye strain |
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heav...
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Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
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| 47 | 2021-02-03 | eye discomfort |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | swollen tongue |
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu...
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Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
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| 47 | 2021-02-04 | tunnel vision |
2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent ...
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2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent numbness". Tingling felt like crawling ants on arm. "more numb in my last two fingers", "discomfort in nape of neck, lightheadedness, and tunnel vision". Patient given 8oz of fluids, PO. BP: 180/105. No medications administered. Transported to ED. Recovered night of 1/16/21.
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| 47 | 2021-02-06 | ringing in ears |
1st Vaccine: soreness in upper arm 2nd Vaccine: Chills, fever, body aches, muscle aches, nausea, ...
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1st Vaccine: soreness in upper arm 2nd Vaccine: Chills, fever, body aches, muscle aches, nausea, dizziness, lethargic, hissing noise from my right ear
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| 47 | 2021-02-06 | swollen tongue, mouth numbness, mouth tingling |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-07 | inability to speak |
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surf...
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#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days. #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough. I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
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| 47 | 2021-02-07 | loss of taste |
Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old f...
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Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 21Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. No known allergies. There is no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient previously took the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 31Dec2020 14:30 at a single dose for covid-19 immunization. The patient experienced Loss of taste on 22Jan2021. There is no treatment received for event loss of taste and no covid test post vaccination. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 47 | 2021-02-07 | visual impairment |
Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (cli...
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Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (clinic) extended by per RN. VS assessed frequently. EMS called due to patients condition not improved but worsening and transported to ER. Patient noted similar reaction with first vaccine. Patient had COVID in September.
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| 47 | 2021-02-07 | dry mouth |
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe...
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Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
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| 47 | 2021-02-08 | double vision, visual impairment | Visual problems, diplopia, concerns for left 4th cranial nerve paralysis |
| 47 | 2021-02-09 | loss of taste, loss of smell, taste disorder |
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas...
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Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
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| 47 | 2021-02-09 | smell distorsion, taste impairment |
Immediate dysosmia and dysgeusia; Immediate dysosmia and dysgeusia; This is a spontaneous report fro...
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Immediate dysosmia and dysgeusia; Immediate dysosmia and dysgeusia; This is a spontaneous report from a contactable other health professional (patient herself). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: 31Mar2021), via intramuscular route of administration in the left arm on 28Dec2020 17:00 at a single dose for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced immediate dysosmia and dysgeusia on 28Dec2020 17:30. The events were reported as non-serious and no treatment was received for the events. The outcome of the events was unknown. The patient had not been tested for COVID-19 since the vaccination.
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| 47 | 2021-02-10 | lip swelling | Angioedema the following morning [ my lips were swollen +3] . No treatment sought . |
| 47 | 2021-02-10 | vision blurred |
My blood pressure which has been stable became elevated. I experienced severe headache for a full da...
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My blood pressure which has been stable became elevated. I experienced severe headache for a full day, a little blurred vision, bp 160s / 100s. My bp remained elevated for several days, is normal today at last check. I saw my primary care provider yesterday and we are monitoring things for a week to see if this passes. If not further testing or medication adjustments may be needed.
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| 47 | 2021-02-15 | eye swelling |
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ...
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With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
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| 47 | 2021-02-16 | ear pain, hearing loss | I have dizziness, diminished hearing, headaches, vertigo and ear pain. |
| 47 | 2021-02-16 | oropharyngeal discomfort, swollen tongue |
roughly 30 minutes after injection, you started to notice difficulty swallowing, tongue swelling. ...
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roughly 30 minutes after injection, you started to notice difficulty swallowing, tongue swelling. took benadryl which improved tongue symptoms, but throat still felt different x 3 hrs. back normal 10-12hr after injection.
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| 47 | 2021-02-18 | eye discomfort |
12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not ...
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12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not right headache got worse 6pm arm started to hurt, headache got worse and so did nausea 10 pm whole body started to ache and chills with major headache and throwing up 4am next day 17th pain through whole body and headache so bad I was dizzy throw in up still 17th hard to walk from total body pain and headache 18th and 19 terrible headache pressure on whole head and neck can?t move neck. Eye pressures
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| 47 | 2021-02-18 | mouth discomfort |
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4...
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After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
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| 47 | 2021-02-18 | mouth tingling |
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15...
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Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine. On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
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| 47 | 2021-02-18 | ear pain | Symptoms: Headache, Nausea, Fever, Aches, Chills, Ear pain, Swollen glands, Fatigue |
| 47 | 2021-02-18 | mouth itchiness, mouth tingling |
The roof of my mouth began it itch the next couple of day my mouth broke out into small red bumps on...
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The roof of my mouth began it itch the next couple of day my mouth broke out into small red bumps on the roof of my mouth and them on the tip of my tongue, on the inside of my top and bottom lip as well. The itching in my mouth started almost immediately but i disregarded it. When the bumps began I began to get concerned hoping it would clear up in a day or so. It has not. I used some meds i had at home for trash but it is not helping much. Everything I eat if it contains salt it burns as well as sodas. My lips are tingling and jumping
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| 47 | 2021-02-21 | taste impairment, mouth numbness, swollen tongue |
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron...
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About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
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| 47 | 2021-02-21 | loss of smell | Loss of smell, high temperature of 104 degrees. |
| 47 | 2021-02-24 | visual impairment |
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past menin...
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Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event. Insomnia, vision changes, agitation. Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
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| 47 | 2021-02-25 | burning mouth syndrome |
Shot #1 12/18, Shot #2 1/15. 2 white lesion appeared on tongue on 1/25. No associated loss of taste,...
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Shot #1 12/18, Shot #2 1/15. 2 white lesion appeared on tongue on 1/25. No associated loss of taste, smell, ulceration, pain, fever. Remained unchanged. Perhaps increased tongue sensitivity. 2/17 photos evaluated by Derm colleagues, concern for COVID tongue, recommended ENT evaluation. 2/18 dentist full oral exam, concern for lichen planus, recommended ENT evaluation. 2/19 evaluated by ENT, concern for lichenoid reaction d/t vaccine. Oral topical steroids started (dexamethasone swish and swallow). Today is day 7 of 9 day course. Appreciable near resolution of lesions. Resolving tongue hypersensitivity.
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| 47 | 2021-02-28 | tongue discomfort, tongue itchiness, mouth itchiness, dry mouth, lip itchiness |
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll...
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Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
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| 47 | 2021-02-28 | mouth numbness, mouth tingling |
Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling trav...
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Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure. Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
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| 47 | 2021-03-02 | lip swelling |
Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a cont...
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Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 47 | 2021-03-02 | bloodshot eyes, eye swelling |
redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with...
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redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with 50mg benadryl. Stayed an additional 30 minutes after benadryl and symptoms continued to improve.
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| 47 | 2021-03-04 | mouth numbness |
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ...
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The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
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| 47 | 2021-03-05 | tongue itchiness, thirst, swollen tongue |
Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s...
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Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s of the tongue about 18 minutes after injection, with a difficulty in ability to swallow. Extreme thirst for about 1.5 hours following the injection. No difficulty breathing, no throat swelling.
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| 47 | 2021-03-06 | vision blurred | Nausea, blurry vision. BP 142/104 (pulse 82). |
| 47 | 2021-03-06 | swollen tongue, mouth tingling |
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ...
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Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
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| 47 | 2021-03-07 | hearing loss |
Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office ov...
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Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office over the phone daily on 03/03, 03/04, 03/05.
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| 47 | 2021-03-09 | eye itchiness, swelling of eyelid, bloodshot eyes | Severe Rash, Itchy Red Swollen Eyes |
| 47 | 2021-03-09 | mouth numbness |
Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of ...
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Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of my tongue feel numb. I also felt a slight nausea. The sensation lasted for about a minute. I told the staff at the hospital that was observing me. It started to subside gradually, but twice while I was still being observed the sensation came back, but not as strong and not for as long as it did the first time. I had no other symptoms. I want to add that I was not anxious about receiving the vaccine and nothing like this has ever happened to me before, but it was quite alarming at the time. I was observed for an hour in total after the shot. I was offered to go to the ER if I wanted to but I declined. It is now about 3 hours since the shot and I feel ok now just slightly tired.
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| 47 | 2021-03-10 | swollen tongue | Tightness of throat and swelling of left side of tongue |
| 47 | 2021-03-11 | lip swelling, mouth numbness |
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ...
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Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
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| 47 | 2021-03-11 | deafness unilateral |
Sudden sensorineural hearing loss that developed over the course of 3 days. Severe to profound heari...
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Sudden sensorineural hearing loss that developed over the course of 3 days. Severe to profound hearing loss in left ear. Responded well to intratympanic dexamethasone and oral steroids. Hearing fully recovered within 2 weeks.
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| 47 | 2021-03-14 | ear pain |
After my second vaccine, I developed severe right earache. It was inflamed and by the night my left ...
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After my second vaccine, I developed severe right earache. It was inflamed and by the night my left wrist had a rash that looked like shingles. I told my doctor about my symptoms and he suspected cellulitis. My doctor gave me ear drops and placed me on antibiotics. So my rash was still present and by the next day I experienced headaches and nausea and felt out of place. I called into work since I did not feel good. On Thursday 01-14-2021, I went back to work but now the same rash I developed on my left wrist was in my right ear. My ENT doctor did lab work and a culture test to check for herpes or shingles, both of these exams were negative and these symptoms lasted one week then they resolved.
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| 47 | 2021-03-15 | eye swelling |
"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pr...
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"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pressure, headache, and swelling of the eyes/face. These symptoms began a few hours after the shot and subsided by Tuesday. I used over the counter medication to treat the symptoms. It was not severe enough for me to feel the need to seek additional medical care. If it had worsened, I would have gone to the doctor"--copied from pt email
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| 47 | 2021-03-16 | eye pain | Moderate headache, pain behind eyes, pain at base of neck, tired, joint pain |
| 47 | 2021-03-16 | mouth numbness |
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower...
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Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
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| 47 | 2021-03-16 | hearing loss, vision blurred |
This is a follow up report starting from day after that first report was made -Report # 244159 - Sta...
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This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
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| 47 | 2021-03-18 | dry mouth |
Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 1...
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Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 16 hours. Insomnia the first night after receiving the vaccination.
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| 47 | 2021-03-18 | lip itchiness, swollen tongue, lip swelling |
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry...
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Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
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| 47 | 2021-03-18 | sensitivity to light, extreme sound sensitivity | Massive headache resulting in nausea, light sensitivity, runny nose, sound sensitivity |
| 47 | 2021-03-19 | vision blurred |
I am really concern because since yesterday I had blurred vision that is getting worse now, feels li...
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I am really concern because since yesterday I had blurred vision that is getting worse now, feels like on and off I am looking through eyelashes. I would like to know if this one will be temporary or if I should call a Doctor. I am also a Dialysis nurse at medical facility. Please let me know.
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| 47 | 2021-03-20 | smell distorsion, swollen tongue |
Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and to...
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Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.
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| 47 | 2021-03-21 | ear swelling, ear pain, sensitivity to light |
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body ac...
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1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea, and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over. My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
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| 47 | 2021-03-21 | visual impairment, vision blurred | Blurred vision, "seeing spots" throughout the day after the vaccination |
| 47 | 2021-03-21 | pain in jaw |
Patient states she is having soreness to her injection site and soreness up her arm, neck and into h...
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Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
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| 47 | 2021-03-22 | ear discomfort |
Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe an...
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Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe anxiety
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| 47 | 2021-03-23 | swollen tongue, inability to speak |
About 40 minutes after inject, had stomach upset, went to gas station across the street, then starti...
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About 40 minutes after inject, had stomach upset, went to gas station across the street, then starting having a tickle in my throat, then coughing, then wheezing, intense headache and sore throat pain like it felt like I swallowed pieces of glass then more wheezing and hard to breathe and losing my voice. Arrived at ER about 1 hour or so after injection time about 12:35 maybe?, they started IV of steroid, benedryl and pepcid rather quickly I don't remember a lot , was very out of it. But the medicine worked and swelling went down on tongue and throat and my voice came back. They prescribed steroids, benedryl, pepcid and zofran because I was and still very nauseous. Taking advil for headache. I think i was home by 4 or 4:30. Still feeling awful today.
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| 47 | 2021-03-23 | ear swelling |
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ...
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After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
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| 47 | 2021-03-23 | ringing in ears | Chills nausea fatigue headache tinnitis soreness for 10 days |
| 47 | 2021-03-24 | visual impairment |
I woke up this morning with a headache so bad that I can barely see out of my eyes. It feels like my...
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I woke up this morning with a headache so bad that I can barely see out of my eyes. It feels like my eyes are going to pop out of their sockets, the headache is that bad.
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| 47 | 2021-03-24 | taste impairment |
Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a c...
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Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 09Mar2021 at 07:58 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (GERD) and ongoing allergies from an unknown date. Concomitant medications included lansoprazole (PREVACID) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient got her first dose of the vaccine yesterday (09Mar2021) and immediately when she was given the injection, she had a metallic taste in her mouth. This lasted 10-15 minutes. She added, she has allergies and she told them that when getting the vaccine. She was told to sit for 30 minutes. She actually sat for 45 minutes instead, but that went away. She later clarified she was referring to the metallic taste that went away. She also had nausea throughout the day. Last night, she took medicine for acid reflux because she has GERD and had stomach upset from the nausea. She clarified she took PEPCID. Then after that, she noticed her mid back was hurting. She is not sure if this is considered a muscle ache, did not really feel like a muscle ache, but it was like a burning type of pain. This was in her mid-back area. It would like to start on one side and rotate to the other and go back and forth. She sent an email to the doctor. She is the one who suggested she get the vaccine because at first, she was not going to get it. The doctor talked her into it. Metallic taste in mouth she did not have after leaving the area. It was a different taste. She was unable to clarify outcome. It was just something she noticed. Nausea: Commented she also take lansoprazole (PREVACID) every day. Last night, she took PEPCID. From what she can tell this morning she has not had nausea. However, she has not gone through the full day yet so would say it's still ongoing, but better. PEPCID (Lot: MHF063, Exp: Mar2021) at 20mg tablet, as needed, for stomach upset. She commented she does not know if she will take the second dose. Stomach upset seriousness criteria was confirmed as medically significant. It has gone away, but medically significant because she did not feel it until after the shot. Mid back hurting seriousness criteria was confirmed as medically significant as it is significant to her even though she is not currently getting treated for it. She still feels the ache. Yesterday, it was like a burning ache. Today it is just an ache on her right side, but still mid back. She does not know if it is a muscle ache. The outcome of the events was stomach upset was recovered on 10Mar2021, Mid back hurting and nausea was recovering, while of metallic taste mouth was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of stomach upset and back hurting due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-03-24 | swollen tongue | Tongue swelling with sores, burning sensation |
| 47 | 2021-03-24 | mouth tingling, feeling of choking, mouth numbness |
first developed tingling in both hands, then developed numbness and tingling in lips, then palate, t...
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first developed tingling in both hands, then developed numbness and tingling in lips, then palate, then throat. She was given water, and while she could swallow, the water felt thick and her swallow felt off/weird. she was given IV benadryl and taken to the ER. There she was given steroids and H2 blockers. She felt her symptoms resolve about 20 minutes later.
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| 47 | 2021-03-25 | sensitivity to light |
15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was take...
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15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was taken to a private section of the arena for monitoring. She had mild tachycardia with heart rate of 105 bpm. With subsequent monitoring, her HR normalized. After 20 minutes of monitoring, her symptoms fully resolved.
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| 47 | 2021-03-25 | ear pain |
20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swell...
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20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swelling in my throat and increased heart rate. I took 10 mg of liquid cetirizine hcl oral solution which I carry with me. I waited an additional 25 minutes at the facility and the itching and swelling and heart rate diminished. I took 800 mg ibuprofen and 1000 mg Tylenol to treat the severe headache. About 30 minutes after that, my headache was much better. I went home and slept for 3 hours and felt almost normal thereafter.
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| 47 | 2021-03-25 | ear discomfort | vertigo like symptoms, dizziness rt ear |
| 47 | 2021-03-26 | ear discomfort, ringing in ears | humming in both ears and ear pressure/stuffiness. feels as though my ears are clogged |
| 47 | 2021-03-30 | lip swelling |
Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, ...
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Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 47 years old) at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Clinic/Veterans Administration facility. Medical history included connective tissue disorder, high cholesterol, and chronic hip/labrum issues, all from an unknown date and unknown if ongoing. Patient was not pregnant. There was no COVID prior vaccination and not COVID tested post vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine for immunization and experienced known allergies: flu vaccine. The patient experienced full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction on 11Mar2021. It was reported that the patient was taken to the ER by EMS for observation, treated and released, all on 11Mar2021. She took Benadryl at the vaccination site and was given prednisone treatment at the hospital. The outcome of the event was recovering. Information on the batch/lot number has been requested.
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| 47 | 2021-04-09 | ear pain |
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a...
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About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
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| 47 | 2021-04-13 | swollen tongue |
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa...
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hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
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| 47 | 2021-04-22 | loss of taste, loss of smell |
There was no place to enter the date of the two above vaccines. The 1st 1 was on 2-22-2021, the 2nd ...
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There was no place to enter the date of the two above vaccines. The 1st 1 was on 2-22-2021, the 2nd dose was on 3-13-2021. On April 17th, I started to have Covid-19 symptoms: runny nose, headache, exhaustion. On the 2nd day, body aches, congestion, headaches, exhaustion. On the third day, all symptoms continue and I lost my sense of smell and taste. No fever ever. On the 4th and 5th day, a runny nose has stopped. all other symptoms continue.
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| 47 | 2021-04-26 | tongue itchiness, mouth tingling |
PT was administered their 2nd dose of Pfizer, and started experiencing symptoms about 15 minutes lat...
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PT was administered their 2nd dose of Pfizer, and started experiencing symptoms about 15 minutes later. Stated that they have history of anxiety, and was having a tightness in their throat. Also was feeling a tingling and itching on their tongue. PT was administered PO antihistamine 50mg. PT cleared the site after waiting additional time under their own power.
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| 48 | 2021-01-04 | ear itchiness |
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minu...
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30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
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| 48 | 2021-01-04 | mouth numbness, mouth tingling |
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em...
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Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
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| 48 | 2021-01-04 | taste impairment |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-04 | visual impairment |
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee...
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I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-01-04 | eye itchiness, ear discomfort, ear pain, eye pain, hearing loss, mouth numbness, mouth tingling |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | swelling of eyelid |
Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelli...
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Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
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| 48 | 2021-01-05 | loss of smell |
12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albutero...
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12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4
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| 48 | 2021-01-05 | mouth tingling |
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ...
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After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
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| 48 | 2021-01-05 | deafness unilateral, ringing in ears, extreme sound sensitivity |
At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I exper...
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At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.
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| 48 | 2021-01-05 | sensitivity to light |
Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two inject...
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Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two injections given to her-Toradol, Zofran, Iv therapy also, prescription for Urrelvy-for migraines-she didn't fill it yet
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| 48 | 2021-01-05 | swelling of eyelid, mouth tingling |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | visual impairment, eye pain |
The next day my left eye was painful, like little ice picks going in, it was inflamed. It was diffic...
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The next day my left eye was painful, like little ice picks going in, it was inflamed. It was difficult to see . I had Lasik about a year ago and I called my eye Doctor because I was nervous and I went to see him and he told me it looked like a allergic reaction. He put me on steroid drops. When I woke up Saturday morning my eye was fine, so I stopped taking the medicine.
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| 48 | 2021-01-05 | lip swelling |
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit...
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chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
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| 48 | 2021-01-05 | eye swelling, ear discomfort |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-06 | taste impairment |
After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay i...
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After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay in the observation area of the vaccine administration site for 10 additional minutes. At 12:00pm patient report throat itching "like chocking". Shock anaphylactic code (RR) was activated. At 12:03pm Epinephrine 0.3mg/1ml was administrated to the left thigh. Venous access was obtained and Solu-Cortef 200mg, Benadryl 50mg and O2 were administrated. Patient vital signs were blood glucose 121mg/dl, Oxygen Saturation 100%, BP 150/90 mmHg. Patient was transfer with the RR code team to the ER for observation.
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| 48 | 2021-01-06 | eye itchiness, bloodshot eyes |
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie...
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Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
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| 48 | 2021-01-06 | taste disorder |
c/o funny taste 10 min after vaccination Narrative: 10 min after vaccination employee c/o funny tas...
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c/o funny taste 10 min after vaccination Narrative: 10 min after vaccination employee c/o funny taste. Denies numbness/tingling to lips or tongue. No difficulty swallowing. Monitored pt for 30 minutes. Emploees states funny taste has resolved.
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| 48 | 2021-01-07 | taste impairment | Metal taste in mouth after receiving the vaccine, headache, fatigue, Fever for 12 hours, dizziness |
| 48 | 2021-01-07 | lacrimation increased |
Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she ...
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Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
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| 48 | 2021-01-10 | swollen tongue, mouth numbness |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | eye pain |
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and...
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Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
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| 48 | 2021-01-10 | ear pain | sore throat, headache, earache. called in sick to work. |
| 48 | 2021-01-11 | hearing loss |
Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report fro...
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Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 29Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced bruise on injection arm on 30Dec2020, caller was difficult to hear during call on an unspecified date. The outcome of events was unknown. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-11 | eye twitching |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | blindness in both eyes | facial swelling, temporary loss of vision in one eye |
| 48 | 2021-01-11 | eye disorder |
hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to v...
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hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # ekj5730), intramuscular at single dose in the right arm on 28Dec2020 13:00 for COVID-19 immunisation. Medical history included migraine, allergies to Codeine, Hydrocodone. Concomitant medications were not reported. On 29Dec2020 11:00, the patient experienced hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine. The outcome of the events was not recovered. No treatment was performed. The patient was not pregnant at the time of vaccination. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
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| 48 | 2021-01-11 | taste impairment | patient complained of metallic taste, body felt heavy, eventually subsided |
| 48 | 2021-01-12 | mouth tingling |
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa...
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11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
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| 48 | 2021-01-12 | mouth numbness, lip swelling, swollen tongue |
Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start...
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Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 48 | 2021-01-12 | thirst |
Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy an...
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Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any distress/discomfort. At 1640, patient complained of itching at injection site. Patient stated she has a history of developing itchy feeling due to adhesive from bandages. Patient removed the bandage. RN administering IM injection inspected site: no swelling, rash, hives, or other s/s of inflammation. Patient still alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any feeling of doom, nausea, vomiting, shortness of breath, elevated heart rate, etc. RN administering injection gave patient an ice pack to apply to left upper arm. Monitoring patient. Patient sitting in chair in vaccine clinic waiting room area. Sipping on H2O due to complaint of feeling thirsty. No difficulty swallowing water. EMS called to Vaccine Clinic for unrelated issue. Once EMS on scene, patient further evaluated by EMS (Biox 98%). Patient asking to be transported to ER. EMS taking patient per patient request.
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| 48 | 2021-01-13 | dry mouth, dry eye |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | lip swelling | FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS. |
| 48 | 2021-01-13 | swollen tongue |
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi...
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Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
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| 48 | 2021-01-13 | pain in jaw |
Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side ...
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Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side of head comes and goes all day. No relief from otc pain meds
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| 48 | 2021-01-13 | lip swelling |
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu...
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Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
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| 48 | 2021-01-14 | mouth tingling |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | swelling around the eyes |
face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat start...
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face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat started 24 hours after vaccine . Severe headache and joint pain started 27 hours after vaccine
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| 48 | 2021-01-15 | dry throat |
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ...
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About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
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| 48 | 2021-01-15 | oropharyngeal discomfort |
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res...
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L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
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| 48 | 2021-01-16 | dry mouth, taste impairment |
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat...
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A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
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| 48 | 2021-01-16 | mouth tingling | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-16 | mouth tingling, swollen tongue |
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t...
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Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
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| 48 | 2021-01-16 | mouth tingling, swollen tongue | Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea |
| 48 | 2021-01-17 | eye swelling |
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an...
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On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
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| 48 | 2021-01-17 | dry throat |
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ...
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Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
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| 48 | 2021-01-17 | mouth numbness, mouth tingling |
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ...
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The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
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| 48 | 2021-01-18 | mouth tingling |
Systemic: TONGUE TINGLING AND FEELING WEEK LIP TINGLING, TOOK BENADRYL WITHOUT CONCERNING PHARMACIST...
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Systemic: TONGUE TINGLING AND FEELING WEEK LIP TINGLING, TOOK BENADRYL WITHOUT CONCERNING PHARMACIST BUT FELT BETTER WITH IT. OBSERVED FEW MINUTES
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| 48 | 2021-01-18 | mouth discomfort, mouth numbness |
not sure if might be related to vaccine. Developed numbness , some redness and peeling off skin i...
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not sure if might be related to vaccine. Developed numbness , some redness and peeling off skin inside of bottom front of the mouth. When rinsing with Listerine, it burns and white patches of skin come off. Feel of burn like from acidic food(lemon, orange, etc.).
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| 48 | 2021-01-19 | bloodshot eyes, eye itchiness, lacrimation increased |
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve...
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Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
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| 48 | 2021-01-19 | lip swelling, mouth tingling | body rash, lip swelling and tingling |
| 48 | 2021-01-20 | mouth tingling |
Felt dizzy and lightheaded, with a heaviness in her head following vaccine administration. Pt also e...
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Felt dizzy and lightheaded, with a heaviness in her head following vaccine administration. Pt also experienced tingling to her lips, and then felt as if she was going to pass out. The staff at the vaccination site gave her epinephrine 0.3 mg/0.3 ml IM, and then brought her to the ED. No acute resp distress in ED, given famotidine inj, methylprednisolone and ondansetron in ED. Given 4 days of Prednisone to continue after ED discharge. Seen by allergist and observed during second dose administration with recurrence of symptoms during divided dose administration.
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| 48 | 2021-01-20 | mouth tingling | Tingly tongue |
| 48 | 2021-01-21 | lip swelling |
Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). ...
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Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). She was being monitored and within 15 minutes her upper lip was swelling. She also had redness on her face. Oxygen levels were stable. Blood pressure monitored and was high (200s/ low 100s). Gave patient 2 tablets of Benadryl. Patient had no throat swelling or trouble breathing. She was taken to the local ER. At the ER, the patient was given steroids. She was release from the ER within a few hours. She is currently at home and is stable.
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| 48 | 2021-01-25 | loss of smell, loss of taste |
I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell r...
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I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell returned quickly but after the 2nd vaccine my taste returned the next day; I had Covid 31Dec-10Jan with both loss of smell and taste initially.; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot-number: EL0104), via an unspecified route of administration in the right arm on 21Dec2020 at 03:00 at a single dose, and the second dose (Lot number: EL3249) via an unspecified route of administration in the right arm on 11Jan2021 at 03:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination, did not have any other vaccine within four weeks, and did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took sertraline (ZOLOFT) and experienced drug hypersensitivity. The patient stated that she regained her taste. She had COVID from 31Dec-10Jan (also reported as on 12Jan2021 at 12:00) with both loss of smell and taste initially. Her smell returned quickly but after the second vaccine, her taste returned the next day. The patient underwent lab tests and procedures which included viral test (nasal swab; Sofia COVID test): positive on 04Jan2021. The patient received no treatment for the events. Outcome of the events was recovered.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
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| 48 | 2021-01-25 | mouth numbness, smell distorsion |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | eye irritation |
Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days...
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Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days Did not take any medications or seek medical attention
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| 48 | 2021-01-25 | oropharyngeal discomfort |
While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given B...
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While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given Benadryl and brought back to first aid tent. Patient developed sore, scratchy throat and headache. No further symptoms before resolve. Give ibprofen.
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| 48 | 2021-01-25 | taste impairment |
headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny ...
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headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny taste in the mouth; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 07:50 at a single dose on Left Upper Arm Muscle for COVID-19 immunization. Medical history included thyroid disorder and antidepressant therapy. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder, duloxetine hydrochloride (CYMBALTA) as Antidepressant and multivitamins. The patient stated that she is calling about the COVID Vaccine, she just had the shot at 7:50AM this morning. After getting the shot she heard that she is not suppose to get the shot if she had tested positive for COVID before the vaccine. She wanted to know if this was true or a rumor. Back around Nov2020 she did test positive for COVID. It was the week before the holidays on Wednesday 18Nov2020 when she lost taste and smell, she then got tested on 19Nov2020 Thursday then got results Friday or Saturday morning, the weekend before the holidays that she was positive. The test was a nasal swab. The girls in the office said she was not suppose to get the shot if it had not been 3 months. When she had COVID shot they didn't tell her if she could take it or not. This morning she woke up everything was fine, she drove over to get vaccine, after they put the vaccine in, they made her wait 15- 30 minute, while waiting she was getting a headache, then the headache went away and she then felt funny in the head. She was a little nauseous then that went away. Then she had this overwhelming feeling of tiredness like she could go to bed. She felt bad a little bit. When she then drove back to work at the school she had this funny taste in the mouth. Her boss wanted to call and see if this is all normal. The date of first dose was 13Jan2021, all the symptoms she experienced occurred within half hour of receiving the vaccine. She thinks she is fine. At the moment she does not have the taste in mouth any longer and her headache left. She still feels funny in head as well as she just feels bad inside, she has the feeling of overwhelming tiredness, she just feels like something is coming on, like she knows she is getting sick. She has no Lot or Expiry to share, she vaccine CDC card is outside in the car and not physically with her. Her drive to get the vaccine was an hour away to a Hospital and all the medication was taken an hour before. She went to the hospital to have the vaccine administered. Then she drove to work at a school. She has had an antibody test, in which they draw blood, it was negative but that was even before she caught COVID, it was back in Aug2020 or Sep2020. She has had no issues with vaccines in the past. The outcome of the event headache, a funny taste in the mouth, and nausea was recovered on 13Jan2021, tiredness/overwhelming feeling of tiredness was unknown, feeling "funny" in the head was not recovered. The events were assessed as non-serious. Information about lot/batch number has been requested.
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| 48 | 2021-01-26 | pain in jaw |
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest...
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Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
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| 48 | 2021-01-26 | swelling of eyelid |
My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experienci...
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My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experiencing it all.
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| 48 | 2021-01-26 | ringing in ears |
Vertigo, Ring in ears and pounding headaches Lasting for 5 days. Needed to be treated with steroids ...
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Vertigo, Ring in ears and pounding headaches Lasting for 5 days. Needed to be treated with steroids for 6 days. Outcome. Still having dizziness and ringing in ears .
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| 48 | 2021-01-28 | dry mouth, mouth tingling, mouth numbness |
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin...
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Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 48 | 2021-01-28 | sensitivity to light |
Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body ach...
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Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body aches, nausea, and very tired. Slept all day, got up for dinner, then went back to bed. Woke up the next day and felt 100% good. I. Other words, had the 2nd dose on Monday morning, Tuesday felt awful, Wednesday felt perfectly fine.
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| 48 | 2021-01-29 | eye twitching |
After Dose 1 of Pfizer COVID vax (on Jan 5) I developed a mild twitch of left upper eyelid (started ...
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After Dose 1 of Pfizer COVID vax (on Jan 5) I developed a mild twitch of left upper eyelid (started on Jan 15, 10 d after vaccine). Persisted, daily - then had dose 2 on Jan 25 and developed more notable twitch of right lower eyelid that was even more persistent and is still ongoing . Never had issues with this before. Not debilitating. Might have nothing to do with vaccine, but thought I'd report in case!
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| 48 | 2021-01-29 | swollen tongue |
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and...
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Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
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| 48 | 2021-01-30 | taste impairment |
Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and sta...
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Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and started to swell. It was a similar feeling to getting contrast through an IV. I took two Benadryl and Ibuprofen to help relieve the symptoms. The metal taste lasted until the next day. Friday- The next morning I woke if with a fever 100° . Minus the mild arm pain, I initially felt ok but as the day went on I felt worse, like the flu. By 11am my heart was racing even at rest. My pulse is usually in the low 60 range (athlete) and it was 95-115 from 11am until late that evening. Saturday- symptoms gone but huge dark circles under my eyes. I felt great though.
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| 48 | 2021-01-31 | taste impairment, eye swelling |
Metal taste in mouth; slight swelling of eyes; This is a spontaneous report from a contactable nurse...
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Metal taste in mouth; slight swelling of eyes; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 21Dec2020 for COVID-19 immunization. On 11Jan2021 02:30 PM, the patient experienced Metal taste in mouth, slight swelling of eyes. No treatment was received. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Jan2021.
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| 48 | 2021-02-01 | dry mouth |
Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightn...
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Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightness in throat, difficulty swallowing and slight confusion begins - drank more water and began to suck on lollipop 5 minute marker - confusion, tightness in throat worsens and lump in throat begins - I alerted medical staff who attended to me and gave me a cold compress. 10 minute marker - Drank water, self administered 2 children's dissolvable Benadryl 20mg - remained at hospital for one hour under observation. 50 minute marker - throat still tight, lump subsided, difficulty swallowing persists, confusion lessens, extreme dry mouth persists, tingling in extremities comes and goes - self administered 2nd Benadryl 25mg 60 minutes - left clinic 90 minutes - called primary care physician and left a message 3 hours - primary care responded to take prednisone 20 - 40 mg every 6 hours for 2 days. 3 hours 20 minutes - all symptoms described above subsided. Prednisone was taken for 36 hours as tightness in throat, issue swallowing and lump came back when I tried to stop the Prednisone at 48 hours.
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| 48 | 2021-02-01 | ear pain |
Started by feeling dizzy today around 11:45 am then a headache that I still have, Around 2:00 pm I ...
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Started by feeling dizzy today around 11:45 am then a headache that I still have, Around 2:00 pm I started with pain in both ears and feeling tired. No feeling well. Right now I laying in bed.
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| 48 | 2021-02-02 | oropharyngeal discomfort |
Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of...
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Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of breath. Patient was administered Benadryl 50mg IVP and was monitored at the site of vaccination. She refused transport. She stated that she felt much better.
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| 48 | 2021-02-03 | loss of taste, loss of smell |
Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19...
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Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19 on 12/31/2020
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| 48 | 2021-02-03 | taste impairment, tongue disorder, swollen tongue, mouth tingling, ear discomfort, eye strain |
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di...
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Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
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| 48 | 2021-02-03 | loss of smell, loss of taste |
Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is ...
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Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
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| 48 | 2021-02-04 | sensitivity to light |
Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I h...
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Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day. Headache remained dull the rest of the day, but I began feeling better. My left arm was also very sore and second day past vaccine now have armpit soreness/pain. Took ibuprofen again today for that.
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| 48 | 2021-02-04 | eye pain |
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si...
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bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
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| 48 | 2021-02-04 | mouth numbness, taste impairment, swollen tongue |
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton...
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it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-05 | blindness |
I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a...
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I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a sudden I felt a heat throughout my body and felt on fire while also feeling an urge of diarrhea and nausea. I tried to go to the bathroom, but kept passing out. I could not see, but was conscious. It took me 15 minutes to crawl to the bathroom. I did not vomit and passed watery stool x 2. The episode passed after about 40 minutes. I continued to have a slight elevated temp all day after that episode, but only 99.6 and below. There were no more issues after that brief, horrible reaction. I am 101 lbs.
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| 48 | 2021-02-07 | toothache |
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c...
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Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-02-07 | sensitivity to light | Pain in arm headache nausea fever body aches joint aches sensitive to light |
| 48 | 2021-02-07 | taste impairment | dizziness, anxiety, metallic taste |
| 48 | 2021-02-16 | eye strain, vision blurred, eye swelling |
After my first dose on 01,18/2021, I was diagnosed with pink eye on 01/21/2021. Took Polymyxin B-Tem...
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After my first dose on 01,18/2021, I was diagnosed with pink eye on 01/21/2021. Took Polymyxin B-Temp eye drops for 7 days. This dose on 02/15/2021, one night after, my right eye again felt heavy, blurry, crusty in corner, and very much like the beginnings of pink eye. Next day, look in mirror, and above iris, there?s a grey discoloration that looks like my iris has shifted down. Upon further investigation, it is swollen. Alrex eye drops prescribed for two days. Return to doctor if not corrected.
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| 48 | 2021-02-16 | taste impairment |
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report...
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Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-02-22 | feeling of choking | Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash. |
| 48 | 2021-02-23 | loss of smell |
chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactabl...
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chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
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| 48 | 2021-02-25 | lip swelling, swelling of eyelid |
Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swel...
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Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swelling in the upper left of lip, swelling in the nose , itchy feeling in the left eyelid and swelling in the right eye lid. Per pt, the swelling is mild and moderately bothersome. We observed the pt for another 60 minutes and pt reported that her symptoms have subsided. However, she still experiences mild nose swelling but she stated that it was much less than before. No medication/treatment was administered. Pt went home and was instructed to contact emergency services if reactions become severe. Pt stated that she may take Benadryl at home.
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| 48 | 2021-02-27 | eye swelling, bloodshot eyes | Swollen eyes...red eyes |
| 48 | 2021-02-27 | swollen tongue | swollen tongue, difficulty swallowing and breathing, itching, rash, headache, ache, fatigue |
| 48 | 2021-02-28 | ringing in ears | 5 hours later developed cough, wheezing, lightheadedness, "ringing in head" but not tinnitus |
| 48 | 2021-02-28 | mouth swelling, eye swelling | Breathing was off, mouth swelling, eye swelling, blood in phlegm |
| 48 | 2021-02-28 | ear discomfort, mouth numbness, mouth tingling |
I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad an...
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I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10. I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.
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| 48 | 2021-03-01 | mouth tingling |
253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gav...
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253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gave diphenhydramine elixir 25 mg x1 307p 120 HR, trouble with BP cuff 313p R arm numbness, legs heavy, face and mouth tingling ? gave diphenhydramine elixir 25 mg x1 315p 142/89, 110 HR ? legs ?wonky?, R arm numbness remains, itching improving 330p symptoms significantly improved, ?feeling better?; family member with patient and able to drive patient at home and continue observation Telephone follow-up performed at 430p. No problems.
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| 48 | 2021-03-02 | eye itchiness, eye swelling | Sneezing; swollen, itchy eyes; swollen throat, difficulty swallowing, rash |
| 48 | 2021-03-02 | vision blurred |
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 ...
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after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
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| 48 | 2021-03-04 | vision blurred |
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ...
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A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
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| 48 | 2021-03-04 | ear discomfort |
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif...
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About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
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| 48 | 2021-03-04 | thirst, lip itchiness, eye swelling |
It started out as an itchy area under the band aid. I took the band aid off and the itching got wors...
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It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
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| 48 | 2021-03-04 | swollen tongue, mouth numbness |
tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmac...
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tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmacist gave me benedryl and made me stay there longer.
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| 48 | 2021-03-05 | eye itchiness | Mild headache, tired, itchy eyes and face, sneezing, congestion, heart racing |
| 48 | 2021-03-07 | swelling around the eyes |
beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge o...
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beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
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| 48 | 2021-03-08 | loss of smell |
mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; C...
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mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
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| 48 | 2021-03-09 | mouth tingling, oropharyngeal discomfort |
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne...
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Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
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| 48 | 2021-03-09 | dry eye |
Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in ...
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Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in neck near implanted surgical metal. Period started 1 week early. Resolved I?m 48 hours with rest, heat packs, Tylenol and Benadryl.
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| 48 | 2021-03-09 | vision blurred |
Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vita...
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Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vitals. Vitals were as followed: P: 98, BP: 149/106, SPO2: unattainable. Pt reported having a history of hypertension and dextrocardia. Pt was breathing well and was able to speak clearly. Pt was AnOx4. Pt stated she has had no food or drink yet today and was nervous for the vaccination. Vaccination site was not raise, inflamed, or warm to touch. Staff concluded pt was most likely experiencing dehydration and anxiety. Staff told pt to monitor symptoms and if any were to return or worsen, to call insurance nursing hotline or 911.
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| 48 | 2021-03-10 | ear pain |
Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a con...
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Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00 pain in left ear on 28Jan2021 19:00 and The patient underwent lab tests and procedures which included body temperature: 97.3 on Temperature under the tongue was 97.3 and outcome of the events was unknown Information on the Lot/Batch number has been requested.
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| 48 | 2021-03-10 | swollen tongue |
MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION....
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MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION. EMS ON SITE. PATIENT TRANSPORTED TO ER. GIVEN BENADRYL AND SOLU-MEDROL ON SITE.
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| 48 | 2021-03-10 | ear pain | Severe left ear pain and pain on the left side of the face, including the neck. |
| 48 | 2021-03-11 | vision blurred |
Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated...
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Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated with ice packs. Began at 4:50pm and resolved at 4:58pm
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| 48 | 2021-03-11 | mouth tingling |
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im...
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Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
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| 48 | 2021-03-13 | mouth tingling |
Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155...
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Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155/95 (pulse 79), 136/90 (pulse 79). Given water and rested.
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| 48 | 2021-03-14 | ringing in ears |
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch soun...
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On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch sound like static. It hasn?t gone away since then. Im seeing an ENT on 3/16/21 to have this checked. About 25 minutes after my covid shot I felt a strong cold feeling on the top of my head for about 30 -60 minutes . It went away. Now I wonder if this was also related.
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| 48 | 2021-03-14 | visual impairment |
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ...
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out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
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| 48 | 2021-03-14 | dry mouth, loss of taste |
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore...
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pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
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| 48 | 2021-03-15 | dry mouth |
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via ...
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2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82 HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
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| 48 | 2021-03-15 | mouth numbness |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-15 | mouth tingling | tingling in mouth and lips, itchiness on neck, given Benadryl IM with improvement |
| 48 | 2021-03-16 | ringing in ears |
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. ...
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After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue. I had my epi pen with me just in case. It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing. When we got to the restaurant to eat, we were the only family in there and it was pretty quiet. The ringing was really high pitched and loud. For the following two weeks it did not stop, day and night. I contacted my primary and had a telehealth appt and also went physically in to my ENT's office. I also tried acupuncture to see if that would take away the ringing. The acupuncture seemed to lower the pitch in my ear but it was still present. 2 hours after I left the office the pitch was back to a high pitch ring again. I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition. I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal. My ENT is unsure if I will lose hearing due to this vaccine.
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| 48 | 2021-03-17 | mouth tingling, lip swelling, swollen tongue |
10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. ...
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10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. Throat tight. Some dizziness. Some chest pain. Some itching (especially scalp and sole of feet and then some on arms). Stayed where medical professionals could see me for about 2 hours. Took Benadryl about 3 hours later (after shot) and lingering symptoms mostly cleared up. 8 hours later still some itching and lips feel a little "off" still. Arm is normal vaccine sore. I have a strong history of repeated anaphylaxis (from MCAS) and this didn't get too serious compared to previous reactions I had to be hospitalized for.
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| 48 | 2021-03-17 | ear pain | Headache Ear ache on the right side Fatigue Chills |
| 48 | 2021-03-18 | taste impairment |
Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second va...
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Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second vaccine. Hard lump under injection site. Minor redness.
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| 48 | 2021-03-18 | ear pain |
Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because o...
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Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because of nurse negligence and human error she overdose me and injected two shots of vaccine one after the other at the same time. Right after the incident they shifted me to emergency and kept me under observation there for almost 10 hours. I am a healthy person of no underline issues but still went through physical and mental trauma. Right after the dose I got dizzy, disoriented, my BP shot up, my heart rate was on the lower side now I am moved to home but have severe body aches, headaches, ear pain and allergic rashes itch on both arms and neck . I am scared if this would affect my health in future.
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| 48 | 2021-03-19 | feeling of choking, mouth tingling |
10 minutes after vaccine pt complained of throat tingling and lip tingling. No swelling present, no ...
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10 minutes after vaccine pt complained of throat tingling and lip tingling. No swelling present, no trouble breathing, no drooling and no trouble speaking. Pt states with her previous allergic reactions this has happened and she needed a steroid shot or a shot of bennadryl (pt couldnt remember which one). Pt had no derm reactions and denied pruritis. We added 15 minutes to her observation time. Symptoms did not progress and they improved a little. She went home and was advised to take an oral benadryl when she got home if symptoms persisted. Pt in agreement with plan.
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| 48 | 2021-03-19 | eye itchiness |
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip...
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2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
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| 48 | 2021-03-19 | taste disorder |
About 30 minutes after the vaccine I got a strange taste in my mouth which lasted about 30 minutes. ...
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About 30 minutes after the vaccine I got a strange taste in my mouth which lasted about 30 minutes. Both of my children 24/19 got their first Pfizer vaccine on 3/19/2021 and told me the same thing happened to them too.
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| 48 | 2021-03-20 | eye strain |
Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, brui...
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Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, bruised, headache for 4 days, eyes tired
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| 48 | 2021-03-20 | taste impairment | Metallic taste in mouth, severe fatigue, muscle, joint, and nerve pain, nausea |
| 48 | 2021-03-21 | pain in jaw |
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n...
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3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
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| 48 | 2021-03-21 | taste impairment |
Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the me...
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Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the medication was traveling across my upper chest to my other arm, brief metallic taste in mouth
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| 48 | 2021-03-21 | thirst |
Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 ...
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Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 woke at 6am extremely tired, woozy, nauseous (no fever). I was able to work from home a little but napped several times. Day 2 on a tired but functional, continued abdominal pain turning late in day to diarrhea (about 48 hours post vaccine). Day 3 morning abdominal pain, diarrhea and tired. Day 4 mostly back to normal. I had covid 90 days prior to the vaccination. I'm scared to get the second dose.
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| 48 | 2021-03-22 | loss of smell, loss of taste |
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr...
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Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
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| 48 | 2021-03-23 | mouth tingling, taste impairment, mouth numbness |
30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The ...
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30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The bottom part of my face was numb. I was also nauseous and I had a metal taste in my mouth. Today is the 5 day since my vaccine and the numbness is less. I did not have facial droop.
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| 48 | 2021-03-23 | mouth itchiness, eye itchiness |
Superficial thrombophlebitis, itching around mouth, eyes, and joints, breathing difficulties - admin...
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Superficial thrombophlebitis, itching around mouth, eyes, and joints, breathing difficulties - administered cetirizine HCl 10mg antihistamine at onset of symptoms and 2 puffs Albuterol Sulfate HFA Inhalation Aerosol 90mcg per actuation approx 90 minutes after onset to control symptoms until they fully subsided.
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| 48 | 2021-03-23 | thirst |
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym...
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Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
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| 48 | 2021-03-24 | mouth swelling |
Client completed 15min observation after vaccine and went out to her car. She noticed a rash on ches...
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Client completed 15min observation after vaccine and went out to her car. She noticed a rash on chest, and a dull headache so she came back in. Client was given 50mg of Benadryl PO and was observed for another 15min. Nurse observed a rash on chest that looked like hives and some redness on her right arm. Client's rash decreased but she did complain of a feeling of thickness in her mouth. There was no difficulty swallowing or breathing. Client was released to leave clinic site at 4:06 pm by RN.
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| 48 | 2021-03-24 | swollen tongue, tongue disorder, mouth tingling |
Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning se...
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Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning sensation by 4:10 my tongue had began to adversely swell to twice its size. I inform the nurses and was immediately taken to the ER where they noticed that my tongue was extremely swollen my throat was beginning to swell and that I had raised up bumps and lesions starting to form on the back side of my tongue. ER staff admitted me and began me on a IV steroid treatment accompanied with Pepcid and Benadryl After 2 hours in the ER under close observation my tongue was still swollen and my windpipe was in danger of being closed off so I was transported via ambulance to Hospital and admitted to Intensive Care Unit where they continued to administer steroids and Benadryl. By 2 a.m. my condition had not improved and I was given an EpiPen in my arm. The EpiPen did help but by 6 a.m. my tongue swelling had returned but not as severe. On march 24th The hospital then moved me from the ICU to the cardiac wing to be placed on a heart monitor as they continue to administer steroids, Benadryl, and Pepcid. I was given another Epi Pen by 11 a.m. in the cardiac care unit due to my tongue beginning to severely swell again. As of today, March 25th My tongue continues to swell and they still have me admitted to the hospital as they continue to observe me and continue to administer steroids and Benadryl all via my i.v. port. Today they are going to begin me on an oral Prednisone.
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| 48 | 2021-03-24 | ear swelling |
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and...
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anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
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| 48 | 2021-03-24 | ringing in ears |
severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/o...
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severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
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| 48 | 2021-03-25 | mouth tingling |
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of...
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40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
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| 48 | 2021-03-25 | vision blurred | Blurring in right eye that comes and goes, constant muscle spasms in stomach |
| 48 | 2021-03-26 | loss of taste |
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, sympto...
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I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
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| 48 | 2021-03-26 | ringing in ears |
Loud tinnitus in both ears but especially the left. Can?t cancel out the sound - it is a constant ...
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Loud tinnitus in both ears but especially the left. Can?t cancel out the sound - it is a constant high pitched and loud ring.
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| 48 | 2021-03-30 | mouth tingling |
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like i...
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Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021. Information on the lot/batch number has been requested.
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| 48 | 2021-03-31 | eye swelling |
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in fa...
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started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-04-01 | ear discomfort |
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca...
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The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
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| 48 | 2021-04-02 | deafness unilateral, ringing in ears | I have developed Tinnitus in my ears since having the vaccine. |
| 48 | 2021-04-07 | ringing in ears |
Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. ...
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Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the left arm on 25Feb2021 at 04:15 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patients medical history included Hashimotos Thyroiditis and Autoimmune Disorder. The patient had Latex, Zythromax, Remeron allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 25Feb2021 at 04:30 PM, the patient experienced face immediate got bright red and my ears started ringing. The tone was reported to be high pitched mostly in the left ear and it has not stopped for six weeks. The patient received Lipo Flavonoid and acupuncture as treatment for the events. The patient underwent hearing test whose reports were not provided. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The clinical outcome of events was not recovered.
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| 48 | 2021-04-07 | ringing in ears |
Within 45 minutes of receiving vaccination I experienced severe tinnitus, headache at the top of m...
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Within 45 minutes of receiving vaccination I experienced severe tinnitus, headache at the top of my head, body aches, fatigue, and neck ache. All symptoms lasted about 2 days except severe tinnitus remains.
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| 48 | 2021-04-09 | dry mouth, vision blurred, sensitivity to light |
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h...
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3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
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| 48 | 2021-04-10 | bloodshot eyes, swollen tongue, eye swelling |
My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just...
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My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just in case adverse reaction. On 04/09/2021 came back for second round. The nurse gave me my 2nd shot and said they don?t make patients wait after injections, I left the facility and by the time I reached my car my tongue had swollen up, went home and later that night my husband and kids asked what was wrong with my eyes - both my eyes were bloodshot red and swollen. On 4/10, my left eye was better but not my right. I have had brain fog, not being able to remember short memories all weekend. I plan to call my doctor in the morning. As a woman, I felt morally obligated to share my side effects.
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| 48 | 2021-04-12 | visual impairment, vision blurred |
mini stroke; having vision issues; having vision issues, she could not focus and started seeing flas...
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mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-04-15 | visual impairment |
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both...
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About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs, dizziness, pins and needles, extreme fatigue, lethargy, feeling the pulse of my heart rate in various part so my body in an opressive kind of way like in my throat, under my right breast, in my back on the ribs usually. All these symptoms never subsided and became noticeably worse a few days after my second dosis on April 8th. My arms are always numb when I get up and become worse when hanging down, of course, but with different intensity. I am feeling extremely dizzy as I walk around and unstable. Walking feels like the ground is further than it is in a way. I do notice a slight shortness of breath but more of an oppression in the rib cage than panting. I have been avoiding walking far or walking my dogs all together. I am not seeing any improvements even after my visit to the Urgency Care where nothing wrong was found on blood work and EKG. I was told to reduce inflammation with dietary supplement and some vitamins. I cannot work of course and what is a bit frightening now is that I am not improving on day 8 of my second dosis! Same rotation of weird symptoms all day (feeling my blood not circulating normally if that can be described even, numbness, pins and needles in arms, and right leg. Sometimes it affects my right cheek. Dizziness and unstability to walk around. Vision is lower as well. Too weak to do anything constructive. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
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| 48 | 2021-04-15 | vision blurred, thirst |
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu...
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Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
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| 48 | 2021-04-21 | ringing in ears |
Chronic Tinnitus was noticed about a week after 2nd shot. In right ear only. Not pulsating. Not tak...
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Chronic Tinnitus was noticed about a week after 2nd shot. In right ear only. Not pulsating. Not taking any meds associated with tinnitus.
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| 48 | 2021-04-23 | lip swelling |
ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and b...
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ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 48 | 2021-04-24 | oropharyngeal discomfort |
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho...
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Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
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| 48 | 2021-04-24 | swollen tongue, mouth tingling, tongue disorder, mouth discomfort, tongue discomfort |
anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; mas...
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anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; massive and dangerous swelling of my tongue; an intense burning on the roof of my mouth; there were bumps forming all over the back of my tongue; blisters forming on the back of my throat; She has been very very sick; This is a spontaneous report from a contactable consumer (patient), other healthcare professional, and a physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (at the age of 48years) as single dose for Covid-19 immunization. Medical history included known allergies: mild allergy to sulfa as a child that resulted in a rash; mild allergy to Crestor that resulted in extreme gas and bloating; other medical history: type 2 diabetic that has been controlled for 8 years with no A1C higher than 7.0. The patient is not pregnant at the time of vaccination. Concomitant medications included metformin, glipizide, bupropion hydrochloride (WELLBUTRIN), lovastatin, and other unspecified medication; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 23Mar2021, she received her vaccine at 4 p.m. and experienced an anaphylactic reaction within 5 minutes, by 4:10 she was taken to the ER (emergency room) attached to the clinic due to her tongue first tingling, then burning all over her tongue, and then massive and dangerous swelling of her tongue and an intense burning on the roof of her mouth. The attending physician noted there were bumps forming all over the back of her tongue and blisters forming on the back of her throat. She was admitted for anaphylactic shock and kept at the ER for 2 hours before being transferred via ambulance to other hospital and she was admitted to the ICU (intensive case unit). She spent the next day in the ICU then 2 days in Cardiac Care, another day back in the ICU, with a 5th and final day back in the Cardiac care. All 5 days were spend trying to get her anaphylactic shock under control. She had numerous doses of EpiPen, steroids, Benadryl, and Pepcid. Her tongue never did completely stop swelling and the burning sensation has never stopped. The patient was hospitalized for 5 days. It was reported further reported that the patient was hospitalized for 6 days (also initially reported as 5 days-pending clarification) and was sent home with medications but was back in the hospital yesterday (unspecified date) because of another big blow up. She has had 2 stays in the ICU, 4 days in cardiac care and is now back in cardiac care again because of yesterday. It has been 2 weeks since she received the vaccine and it is now day 12 but it keeps coming back and she just cannot stop it. She has been very very sick, in a very severe, very rare, extreme, constant state of anaphylactic shock. She has had many Epi (Epinephrine) and is on strong steroids but it has not subsided. She mentioned that their lead pharmacist called last week but never heard any response back. Her doctor told her that they accessed a website from Pfizer which allowed them to search for adverse reactions and they mentioned to her that most of these reactions subside within 24-48 hours. She mentioned that she has no food allergies, no allergies to vaccines, and has only had minor drug reactions. This is the 1st time that this has happened to her and it is getting serious. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. The reporter (consumer) assessed the events as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 48 | 2021-05-04 | swollen tongue |
Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; T...
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Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; This is a spontaneous report received from a contactable other hcp. A 48-years-old female patient received first dose of (Solution for injection), via an unspecified route of administration, administered in Arm Left on 26 Jan 2021 18:30 as single dose for Covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications included Hydrochlorothiazide and Betahistine. It was reported that patient was not pregnant at the time event. On 26 Jan 2021, the patient experienced red hives starting at neck and chest and radiating to arms and face, lightheaded and swollen tongue. The events were non-serious. Patient received Benadryl as treatment for events. It was reported that patient was not taken any vaccine in four weeks nor had Covid and tested the same post to vaccination. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-09 | deafness unilateral | Sudden, permanent, unilateral hearing loss on same side of injection, |
| 48 | 2021-05-11 | eye swelling, swelling around the eyes |
Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face w...
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Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-05-12 | eye pain |
stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and le...
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stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. She had fell on both arms, she's had a knee surgery and its like going to that. The knee surgery was on the right knee. Like right now its in her back, and she can barely walk because she pulled a back muscle before. She stated that she will enjoy it if she can walk again and she just wanted to make it through this. The adverse events did not require emergency room visit or physician's office visit but was definitely at the point where she will go see the primary or go to the ER. The outcome of the event vasculitis pain flare up, right and left arm pain/legs hurt/hands were also hurting, and ?can't walk was not recovered; for knee pain, whip lash in shoulders and neck, feel radiation or heat, uncomfortable, and shoulders became sore, it was recovering at the time of report; for the other events, it was unknown. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-01-01 | eye pain, eye itchiness, eye irritation |
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ...
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12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
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| 49 | 2021-01-03 | lip swelling |
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ...
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I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
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| 49 | 2021-01-03 | vision blurred, mouth numbness, taste disorder |
On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste li...
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On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.
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| 49 | 2021-01-03 | mouth numbness, mouth tingling |
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ...
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Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
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| 49 | 2021-01-03 | mouth swelling, mouth tingling |
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou...
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Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
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| 49 | 2021-01-03 | mouth tingling |
tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable...
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tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable other hcp(patient). The 49-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration at left arm on 21Dec2020 at single dose for COVID-19 immunization. There were no concomitant medications nor medical history. Patient got first dose of the COVID vaccine and experienced her lips tingled/ tingling of the lips and her throat got tight, both on 21Dec2020, led to medically significant, lasted about 20 minutes. They observed her and she did not need any further treatment. Outcome of events was recovered in 21Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of her lips tingled/ tingling of the lips and her throat got tight cannot be excluded, considering the plausible temporal relationship and the known adverse event (anaphylactic adverse reaction) profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 49 | 2021-01-04 | eye pain, mouth pain, mouth numbness, burning mouth syndrome |
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are...
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Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
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| 49 | 2021-01-04 | mouth tingling, mouth numbness |
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af...
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I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
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| 49 | 2021-01-04 | oropharyngeal discomfort, mouth tingling |
Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. With...
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Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. Within the 30 minute waiting period, she felt like her lips and tongue were tingling and her throat was scratchy. She denied shortness of breath, chest pain, difficulty swallowing or difficulty breathing. Vital signs were stable. Due to her history of anaphylaxis reaction with various medications and shellfish, she was taken to the ER. In the ER she received IV Solu-Medrol, Benadryl and Pepcid and her symptoms resolved. She was observed for 6 hours and then released to home.
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| 49 | 2021-01-04 | swollen tongue | Woke up to an enlarged tongue - could not close mouth or eat |
| 49 | 2021-01-04 | eye swelling, swelling around the eyes |
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p...
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left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
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| 49 | 2021-01-05 | eye swelling, thirst |
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha...
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Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
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| 49 | 2021-01-05 | bloodshot eyes |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | swelling around the eyes, lip swelling |
periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than...
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periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO
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| 49 | 2021-01-06 | vision blurred |
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained ...
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@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips. Â @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better." Â Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days. Â Pt advise to call if s/sx return or get worse. Â Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
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| 49 | 2021-01-06 | taste impairment | Metallic taste in mouth started about 5 minutes after injection. lasted approximately for 1 hour |
| 49 | 2021-01-06 | vision blurred, mouth numbness | Numbness of mouth,blurry vision for 24 hrs post vaccine |
| 49 | 2021-01-06 | mouth tingling |
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ...
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Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
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| 49 | 2021-01-06 | mouth tingling |
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos...
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Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
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| 49 | 2021-01-06 | mouth numbness | rt. orbital numbness, lip numbness |
| 49 | 2021-01-06 | feeling of choking |
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo...
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throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 49 | 2021-01-07 | oropharyngeal discomfort | Caregiver complained of a "heavy" throat and had redness and itching to her neck and chest area |
| 49 | 2021-01-07 | eye pain |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | ear pain |
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea S...
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Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later
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| 49 | 2021-01-07 | ear pain |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | taste impairment |
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove...
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Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
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| 49 | 2021-01-07 | mouth numbness |
Numbness noted left lower lip area noted when woke up the morning after COVID19 Vaccine. The numbne...
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Numbness noted left lower lip area noted when woke up the morning after COVID19 Vaccine. The numbness subsided before noon same day
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| 49 | 2021-01-07 | loss of smell, loss of taste |
Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and...
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Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and loss of taste & smell. 1/8/2021 tested positive for Covid.
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| 49 | 2021-01-07 | lip swelling, swollen tongue |
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc...
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Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
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| 49 | 2021-01-07 | mouth numbness |
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1...
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developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
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| 49 | 2021-01-08 | double vision |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | lip swelling | Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins |
| 49 | 2021-01-08 | eye pain, bloodshot eyes, vision blurred |
BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrati...
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BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrative: Took Tylenol 500mg, 1000mg BID
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| 49 | 2021-01-08 | ringing in ears |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | swollen tongue, mouth itchiness |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-09 | ringing in ears |
1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Cough...
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1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Coughing, runny nose, congestion, fever, ringing in ears, 3rd day musculoskeletal & joint pain, inner ear pain, fatigue, cough, throat pain This is 3rd day and I am still miserable
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| 49 | 2021-01-10 | taste impairment |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-11 | visual impairment, vision blurred, lip swelling |
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We...
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1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
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| 49 | 2021-01-11 | taste impairment |
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou...
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Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
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| 49 | 2021-01-11 | smell distorsion, deafness |
Had diminished hearing loss for 1 day, and sense of smell was affected, smelled vomit all day. This ...
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Had diminished hearing loss for 1 day, and sense of smell was affected, smelled vomit all day. This was the day after the vaccine. On Friday, I was back to normal. Thank God! No treatment needed.
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| 49 | 2021-01-12 | eye floaters |
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She repor...
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About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63, pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
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| 49 | 2021-01-12 | mouth tingling | Tingling on tongue and lips, fever 101.0, nausea |
| 49 | 2021-01-12 | tunnel vision |
about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No ...
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about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No diarrhea but soft stools. today headache, and fatigue
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| 49 | 2021-01-12 | eye swelling |
woke up with swollen eyes - both; a similar reaction the medication is Myrbetriq and had an allergic...
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woke up with swollen eyes - both; a similar reaction the medication is Myrbetriq and had an allergic reaction; researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1284, expiry date not reported), via an unspecified route of administration on 05Jan2021 16:30 at a single dose in the right arm for COVID 19 immunization. Medical history included COPD, Hashimoto's and celiac (celiac disease gluten), all were ongoing. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medications included levothyroxine sodium (TIROSINT), acetylsalicylic acid (BREOPRIN), indometacin (VANTELIN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), and cetirizine hydrochloride (ZYRTEC). The patient previously took epinephrine and experienced allergies wherein patient required carbocaine at dentist; and mirabegron (MYRBETRIQ) and patient had an allergic reaction (approximately 2 years ago). The patient had no other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered in the hospital. They kept the patient for 15 minutes to 20 minutes. She began to have symptoms later that night, both eyes looked like she had been punched, swollen shut when she woke up in the morning. It was also reported as he morning after shot, 06Jan2021 06:00, patient woke up with swollen eyes (both); no swelling anywhere else; swelling continued into mid-afternoon when called into nurse line to report at hospital. Patient reported on Pfizer website the adverse effects but forgot to put in the report medication she was taking and had a similar reaction the medication is Myrbetriq and had an allergic reaction to this medication as well (2 years ago). Patient researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol. Patient was advised to take benadryl and cold compresses for swollen eyes (both). They told patient to take benadryl one pill and if symptoms didn't subside to take another Benadryl. She took one benadryl and began to see slight improvement. She took the second benadryl and at around the 2 hour mark she was "pretty good, swelling totally gone and feeling totally okay, it took about 6 hours". The patient had no other symptoms. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Patient stated that no one seemed to be able to tell patient if patient can take the second dose. Patient stated that she found information on CDC website regarding time of onset and ability to take second dose. The event swollen eyes (both) recovered on 06Jan2021; reported as swelling went away by dinner time on 06Jan2021 and eyes were fine at the time of the report. The outcome of the events "allergic reaction" and "researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol" was unknown.
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| 49 | 2021-01-13 | pain in jaw |
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on...
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-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
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| 49 | 2021-01-13 | loss of taste, vision blurred, loss of smell |
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches...
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1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
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| 49 | 2021-01-13 | lacrimation increased | On 24 I had sinus and watery eyes. I went to ER because I was congested and coughing. |
| 49 | 2021-01-13 | taste impairment |
SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she beg...
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SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she began feeling her throat was scratchy, mouth tasted metallic and a flushed felling over her entire body. SM attached to VS machine. Initial set of vitals were HR 77 bpm, spo2 100% on RA, and left arm blood pressure 158/84.
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| 49 | 2021-01-13 | vision blurred |
blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headac...
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blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headache (almost as bad as the spinal headache from my 1st child) , chills, fatigue, nausea. Called PCP and he gave me Tylenol with codeine for the headache and a prednisone for the asthma even though it was under control.
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| 49 | 2021-01-14 | swollen tongue |
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm sorenes...
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She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl and 40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
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| 49 | 2021-01-16 | smell distorsion, taste disorder |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-17 | taste impairment |
*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minu...
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*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minutes after the shot was administered. *42 hours after administration of vaccine, I woke up with a metalic taste in my mouth which has laste for 6 hours
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| 49 | 2021-01-17 | vision blurred |
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp...
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headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
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| 49 | 2021-01-18 | mouth numbness |
Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was ta...
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Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was taken by observer, pt ultimately felt well enough to go back to her office. At some point she contacted her doctor by phone and came back to observation reporting numb tingly lips and cheeks (covered by mask). Requested a diphenhydramine 50mg, which was given at 1400. rated reaction feel as level 5. After 25 minutes asked again and rated level 1. Contacted doctor. He cleared her to go home and would follow up in 2 hours to see how she was doing.
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| 49 | 2021-01-18 | loss of taste, loss of smell |
covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches heada...
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covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches headache & pain in left arm. some shortness of breath. 2nd injection headache w/ fever some aches still have headaches & a slight cough
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| 49 | 2021-01-19 | mouth numbness |
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my...
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29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
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| 49 | 2021-01-19 | swollen tongue |
Complaints of "tongue feeling fat" kept additional 15 minutes. Symptoms not worse, encouraged to c...
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Complaints of "tongue feeling fat" kept additional 15 minutes. Symptoms not worse, encouraged to call md if symptoms got worse and to take Benadryl. She was able to tolerate drinking water with no issues. She wanted to go home as she had worked the night before.
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| 49 | 2021-01-19 | eye pain |
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil...
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Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
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| 49 | 2021-01-19 | dry mouth |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | swollen tongue |
Pt reported feeling like her tongue was swelling 10 minutes after receiving vaccine. Physical exam n...
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Pt reported feeling like her tongue was swelling 10 minutes after receiving vaccine. Physical exam normal. Vital signs stable. Benadryl 50 mg PO administered. Vital signs remained stable. Pt monitored by physician, NP and EMS. Pt tolerating liquids. Pt denies chest pain, shortness of breath, numbness/tingling, difficulty swallowing, nausea/vomiting. Pt reported resolution of symptoms within 10 minutes after Benadryl administered.
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| 49 | 2021-01-19 | swollen tongue |
Pt reported tongue feeling swollen 10 minutes after receiving vaccine. Physical exam normal, vital s...
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Pt reported tongue feeling swollen 10 minutes after receiving vaccine. Physical exam normal, vital signs stable. Denies SOB, CP, NVD, difficulty swallowing. Monitored for 45 minutes, vital signs remained stable. Gave benadryl 50 mg, symptoms resolved.
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| 49 | 2021-01-19 | mouth tingling |
She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any di...
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She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any difficulty breathing. I took vital signs: HR: 64, BP 128/92, O2: 100%. Observed for additional 15 minutes. She stated that she felt better and decided to go home. I recommend that she check in with her health care provider if symptoms come back or worsen.
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| 49 | 2021-01-19 | swollen tongue | Tongue swelling, throat and chest tightness |
| 49 | 2021-01-19 | mouth numbness |
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t...
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Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
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| 49 | 2021-01-20 | taste disorder, sensitivity to light, smell distorsion |
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo...
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Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
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| 49 | 2021-01-20 | vision blurred | Patient started to feel dizzy, blurred vision and pounded headache from 1/17/21 to now. |
| 49 | 2021-01-21 | mouth numbness |
At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied...
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At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied pain. No antidote nor supportive treatment given. After ~40 minutes of observation, minimal numbness and no SOB. Patient left clinic.
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| 49 | 2021-01-22 | mouth numbness |
I did not administer the vaccine. Pt was treated by doctor over the phone following the event and fo...
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I did not administer the vaccine. Pt was treated by doctor over the phone following the event and followed up in person 2 days later. She reported a numb/ strange sensation in her lips and tightness in her face that resolved with taking Benadryl.
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| 49 | 2021-01-22 | ringing in ears, ear discomfort, ear pain |
The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my rig...
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The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my right ear, that extended deep into region of Eustachian tube. This lasted ~ 1 hr and finally subsided just before I was getting ready to take a Benadryl. The itching returned intermittently over the next 3 weeks, and was bothersome. This was accompanied by the feeling of warmth about the ear occasionally. One incidence of tiny pains in the ear occurred. After ~ 18 days, a gradual onset of ringing in the ears began. This worsened on day 19 , becoming twice as loud. At this point , I deferred the second vaccine dose which was scheduled for day 19, 1/22/21.
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| 49 | 2021-01-24 | mouth numbness |
Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness pers...
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Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness persisting but is better when taking vitamins. Seems worse in afternoon
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| 49 | 2021-01-24 | visual impairment |
I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. ...
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I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. on 1/15/2021 I woke up with severe rigors that lasted 2 hours. Over the course of the day 1/15/2021 I had a second 2 hour episode of rigors. They were almost violent and seizure-like. In addition, I had severe nausea, dizziness, decreased vision, fever, myalgia, and exhaustion. My temperature reached 103.4 and lasted over 24 hours. Ibuprofen would bring the fever down 1 degree and helped decrease rigors, but did not help the headache. On 1/16/2021 I developed redness and swelling of entire upper left arm, and edema in arm pit. I spent three days unable to work or sit up in a chair. Symptoms began to decrease after three days, but I was unable to resume full work days until 1/22/2021. Vision returned to 100%, and nausea resolved, on 1/23/2021. Decreased appetite and fatigue are still an issue as of 1/25/2021.
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| 49 | 2021-01-25 | eye swelling, lacrimation increased |
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO...
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12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
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| 49 | 2021-01-25 | mouth numbness | Facial numbness that started at the upper palate then progressed across the middle of the face |
| 49 | 2021-01-26 | mouth tingling |
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ...
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Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
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| 49 | 2021-01-27 | taste impairment |
Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from...
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Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 14Jan2021 15:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (IBUPROFEN). The patient previously took Augmentin and experienced allergy. On 16Jan2021 07:15, the patient experienced dizzy, nauseous, a strong taste of metal in my mouth, extreme gas. The outcome of the events was unknown. The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Information on the Lot/batch number has been requested.
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| 49 | 2021-01-27 | swollen tongue |
Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, ...
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Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, swollen tongue, difficulty swallowing, headache, extreme fatigue
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| 49 | 2021-01-27 | eye swelling |
Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccin...
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Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccine. It is unknown where the patient received the vaccine, since it was outside our facility. The ED report states the patient woke up with eye swelling (bilateral). red rash on trunk. After contacting the patient, on 25 January 2021, the patient stated that she also began using a Lotus flower facial cream that she believes may have been the cause of the reaction.
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| 49 | 2021-01-27 | taste impairment |
Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes afte...
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Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes after injection. Patient noted that symptoms were mild and were improving. She declined EMS services/hospital evaluation and elected to go home after appx. 30 minutes of observation. HR and BP were both within normal limits.
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| 49 | 2021-01-27 | swollen tongue |
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was...
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Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN. EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.
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| 49 | 2021-01-27 | swollen tongue |
Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen ...
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Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen tongue, Difficulty in breathing
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| 49 | 2021-01-27 | feeling of choking |
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states s...
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c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
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| 49 | 2021-01-28 | loss of smell, loss of taste |
At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really...
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At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really tired and my body was achy. My left arm was sore. The next day roughly the same symptoms throughout the day, really tired and just kinda achy. On a Holiday after I had the vaccine, when I took the ibuprofen, my husband realized he lost his sense f taste and smell and he realized he was the same way the day before. He got tested Saturday the day after the Holiday and since I was still achy on Saturday I called employee health and they told me to get tested. I was tested through Employee Health ( employee only testing site). I still get tired really quick, I get winded really quickly even after doing chores at the house, like laundry and even if I am sitting still, I still sometimes am short of breath. The dull headaches are still present. I had lost my sense of taste and smell but those came back.
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| 49 | 2021-01-28 | vision blurred |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-01-28 | eye swelling |
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no...
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Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | loss of taste, loss of smell |
This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female ...
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This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) intramuscular on 10Jan2021 10:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The first dose of BNT162B2 (Pfizer brand) for COVID-19 immunization was administered on 23Dec2020 08:00 AM intramuscularly in the left arm (at the age of 49 years old). On 15Jan2021, patient was unable to smell or taste at 6 day post injection. No treatments received in response to the events reported. Patient had Covid test post vaccination as Nasal Swab, Pcr on 15Jan2021 with negative result. The outcome of the events unable to smell or taste at 6 day post injection was not recovered. Information about lot/batch number has been requested.
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| 49 | 2021-01-29 | mouth numbness | Next day noted numbness upper lip and beneath eye. Most pronounced for 1 hr. Has been improving |
| 49 | 2021-01-31 | sensitivity to light, extreme sound sensitivity |
I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I woul...
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I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I would consider a migraine (light and sound were painful). I also had bubbly feelings in my stomach that came in waves. The headaches have gotten better in the last 2-3 days.
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| 49 | 2021-01-31 | eye swelling, lip swelling | Systemic: Other- facial swelling- lips and eyes-Medium |
| 49 | 2021-02-01 | vision blurred |
Blurry vision, dizziness, given water and juice. BP/pulse: 102/63, 73; 97/63, 73. O2 sat 100%. 90 mi...
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Blurry vision, dizziness, given water and juice. BP/pulse: 102/63, 73; 97/63, 73. O2 sat 100%. 90 minutes later, feeling better and discharged to home.
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| 49 | 2021-02-01 | eye itchiness |
I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection...
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I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection was a tad sore, nothing out of the ordinary. Sunday morning my husband noticed I had a rash on my throat/neck and around my eyes. They were not itchy at all or bothering me. My inside of my throat was a little scratchy, but not closing at all. I put hydrocortisone cream on neck & throat Sunday night, Monday, rash, hives, scratchy throat were the same, Monday night after my shower, they were extremely itchy, I again put hydrocortisone cream on my neck and around eyes, it was still itchy and getting onto my eyelid, Monday my face was very blotchy and itchy, I called my doctor, who saw me right away, the doctor told me NOT to get the 2nd vaccine, he is concerned about an anaphylactic reaction and to take Benadryl. Doctor told me he would be researching if I could get another brand, ie. the Johnson & Johnson 2nd dose? Now, I am very nervous to get a 2nd dose and do not know if I should cancel my 2nd dose or not? I do not know who else to talk to about it?
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| 49 | 2021-02-01 | lip swelling |
Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous repo...
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Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-02 | sensitivity to light |
Had intense headache for 72 hours straight where I could not withstand any light - the best way I co...
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Had intense headache for 72 hours straight where I could not withstand any light - the best way I could describe it is my migraine had a migraine. Would get dizzy when I stood up. Nauseous and extreme fatigue for 3 days. Slept for 16 hours within 24 hours of receiving the vaccine, day 2 slept for 12 hours but then was up due to vomiting/diarrhea (for 6 hours) about 56 hours after injection and then slept another 12 hours on day 3 after injection. Had a slight sore throat as well. By day 4 all symptoms had resolved.
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| 49 | 2021-02-02 | mouth tingling |
Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to s...
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Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to stay and be observed another 30 minutes. B/p rechecked 163/85. Patient discharged to home at 13:05. Advised to call PCP with any further problems.
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| 49 | 2021-02-02 | eye itchiness, dry mouth |
Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side an...
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Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side and felt like it was burned. Resolved in 3 -4 days Dry mouth. Resolved in 3-4 days
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| 49 | 2021-02-03 | mouth tingling |
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. S...
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Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. She was given Benadryl 50 mg IM at 1117
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| 49 | 2021-02-03 | ear pain |
Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until a...
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Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until about 5 PM and then I felt very ill. Had a fever (highest was 100.8) (which lasted for days) - at least a week that it was 99.9Pand started getting joint pain and muscle aches; nausea; headache. The 30th was a terrible night. I called the DR. that night and they had me come into a COVID test on the 31st. Terrible head pain and earache - amoxicillin for my ears; Dexamethasone - for steriod for the body aches and pains; Norco - or Hydrocodone - I took that as a half a pill a night for 3 or four nights. Z-pack for three or four nights when I started getting chest congestion. I was off work until 15th when I went back to work. I was not 100% but tired. I'm slowly getting better and second dose of the vaccine on the 19th (and I was sick that night - had a high fever - 101.9). Was 24hours of dry heaving; called in sick on the 20th but felt better by the afternoon. Hospital to get the prescription for the ear pain (it might have been on the 5th or 6th of January in the middle of the night).
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| 49 | 2021-02-04 | mouth numbness |
A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hou...
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A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hours after shot: Swelling and small lump formed on left wrist, last appx 16 hours 2 days after shot: Small lump and soreness along the left collar bone area, lump, soreness still ongoing (as of 2/5/2021, date of this report) 2 days after shot: Soreness in both breast, still ongoing (as of 2/5/2021, date of this report)
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| 49 | 2021-02-04 | tongue itchiness |
Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after CO...
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Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after COVID vaccine she experienced SOB, throat and tongue itching, flushing, very anxious, her BP 144/102, HR 120s, RR 20. She had Epi-pen and we injected it for her per her request. She transferred herself to a wheel chair and went to ER with Crisis Nurse. Symptoms resolved. Patient discharged from ED.
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| 49 | 2021-02-04 | mouth numbness |
about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Wok...
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about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better. Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.
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| 49 | 2021-02-06 | tongue itchiness | tachycardia hypertension itchy tongue and throat |
| 49 | 2021-02-07 | dry mouth, taste impairment |
After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave...
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After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave water and observed for 40 minutes. Oxygen was 98-100% HR 70-78 BP 146-150/96-100s. Symptoms lasted around 1 hour. After arriving home BP was 110/78. Patient felt better. No hospitalization needed. Next day patient felt Body aches, Head ache, fever last 20 hours. Patient feels better today 2/8/2020 the only symptom left is fatigue.
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| 49 | 2021-02-08 | mouth tingling |
As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis...
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As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis, urticaria on chest, tongue tingling and thickness in throat. P118 BP 180/100 Treated with diphenhydramine 50mg PO, observed for 40 min, discharged home, told not to get a second COVID vaccine and with the instruction to go to ER if anything else developed. Subsequently she was told by an allergist she could not get a second dose unless there are specialized facilities. She did NOT recieve a second dose. FYI - under our protocol she should have recieved epinephrine
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| 49 | 2021-02-08 | lip swelling | Tuesday morning I was very fatigued and my bottom lip was swollen |
| 49 | 2021-02-09 | mouth tingling |
Shortly after injection, she became light headed with nausea, lip tingling, SOB and felt as if throa...
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Shortly after injection, she became light headed with nausea, lip tingling, SOB and felt as if throat was closing. Moved her to the ER where she was given EPI, Benadryl, Pepcid, Steroids, and Zofran Was later discharged home
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| 49 | 2021-02-10 | mouth tingling, ear pain |
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels ...
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Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
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| 49 | 2021-02-10 | dry mouth |
Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation...
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Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation. I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well. I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
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| 49 | 2021-02-11 | visual impairment |
1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, ...
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1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, admitted to Hospital.
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| 49 | 2021-02-14 | mouth tingling |
Patient c/o mouth & tongue tingling, lightheadedness. Patient reported taking 1pm insulin and not e...
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Patient c/o mouth & tongue tingling, lightheadedness. Patient reported taking 1pm insulin and not eating. Given 2 pieces of candy, coke. EMS called at 1706. EMS arrived, assessed pt and checked FSBS which was 124 after 2 pieces of candy and a coke. Patient declined transport to hospital for further evaluation.
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| 49 | 2021-02-16 | bloodshot eyes, hearing loss, eye irritation, deafness, ringing in ears |
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver...
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About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
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| 49 | 2021-02-16 | eye swelling |
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac...
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Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-16 | mouth tingling |
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. Th...
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Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. That was it until later that night I started getting a really bad headache/migraine. I started taking Tylenol but that didn't help much. I got chills and I'm sure a slight fever because I was sweating. I started throwing up also.. After taking Tylenol every 4 hours my headache finally went away and I started to feel better. This was around 2:30 pm the following day. I would say my symptoms lasted for about 22 to 24 hours.
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| 49 | 2021-02-18 | mouth numbness |
approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac...
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approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
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| 49 | 2021-02-18 | mouth numbness |
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of ...
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tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC which is still there. headaches come and go
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| 49 | 2021-02-21 | lacrimation increased, eye twitching |
Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey....
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Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.
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| 49 | 2021-02-24 | ringing in ears, eye pain |
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red...
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12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
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| 49 | 2021-02-24 | mouth tingling, tongue disorder |
Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing...
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Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing. Could not clear throat. It felt as if I was put inside a CS chamber. Went to ER. Treated with steroid and antihistamine. Coughing stopped with residual tightness in chest. Tingly stopped and reduced itchiness.
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| 49 | 2021-02-25 | swollen tongue |
Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID...
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Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID. Transferred to the ED as by rapid response. Diphenhydramine 50 mg IV and prednisone 60 mg PO administered. Monitored for approximately 1 hr 20 minutes in ED. Symptoms improved. Patient released with prescription to continue prednisone 60 mg/day x 5 days and cetirizine 10 mg/day prn at home.
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| 49 | 2021-02-26 | mouth discomfort, mouth numbness |
Post vax 2wks; numbness on ventral surface of tongue, limited to center of mass. Approximately 5 or...
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Post vax 2wks; numbness on ventral surface of tongue, limited to center of mass. Approximately 5 or 6 days in, noticed enlarged papillae limited to numb area. Sense of taste & smell don't appear to be affected, but sensation (i.e. "feeling) is similar to a burned tongue but lasting a week to date.
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| 49 | 2021-02-26 | feeling of choking | Throat tingling, flushed, diaphoresis, increased blood pressure to 160's, |
| 49 | 2021-02-27 | ringing in ears | Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach |
| 49 | 2021-02-27 | sensitivity to light | Headache, eyes sensitive to the light, nausea, soar arm. |
| 49 | 2021-02-28 | taste impairment |
All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my m...
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All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my mouth, headache, sore arm, itchiness on legs and back, rash on inner thigh
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| 49 | 2021-02-28 | mouth tingling |
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport t...
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Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
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| 49 | 2021-02-28 | mouth tingling |
Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced di...
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Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced diffuse itching with oral paresthesia and cough. No globus or SOB. Seen in Urgent Care. No hives or other rash recorded. Vital signs stable. Treated with oral decadron and benadryl and released after >1 hour observation with resolution of sxms.
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| 49 | 2021-03-01 | feeling of choking, taste impairment, mouth numbness, mouth tingling |
Patient reports approximately 45 minutes after administration of the vaccine she developed a metalli...
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Patient reports approximately 45 minutes after administration of the vaccine she developed a metallic taste in her mouth, followed by tingling and numbness in her lips, tongue, and tingling in her throat. She reports she took Benadryl sometime after this, and then eventually the sensation and taste resolved.
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| 49 | 2021-03-02 | mouth numbness | lip going numb four days after vaccination |
| 49 | 2021-03-03 | mouth numbness | Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given. |
| 49 | 2021-03-03 | eye pain |
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet...
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Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
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| 49 | 2021-03-04 | dry throat |
1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Wa...
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1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Warmness to arm resolved 1500. anxiouness resolved 1505. throat cont to be dry able to drink water w/o difficulty. drank one full bottle of water. Report sensitive and has many allergies. Pt husband is in car and informed of pt condition. 1520 pt condition dryness in needs to take mask off.. went outside totake off and get fresh air. 1540 128/89-hr-122-02 sat 96%ra r-18. Pt instructed to f/u with MD has appointment on tuesday. upon discharge reports tired and dry throat.
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| 49 | 2021-03-04 | taste impairment, mouth tingling, mouth numbness |
Observed for 30 minutes post vaccination. 45 minutes post vaccination had metallic taste, tingling ...
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Observed for 30 minutes post vaccination. 45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/ Contacted PCP.
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| 49 | 2021-03-04 | dry mouth |
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa...
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Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
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| 49 | 2021-03-04 | eye irritation |
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ...
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She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
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| 49 | 2021-03-05 | swollen tongue | Difficulty breathing, swollen tongue |
| 49 | 2021-03-05 | ear pain | congestion, elevated temperature, ear pain |
| 49 | 2021-03-06 | mouth numbness, taste impairment, mouth discomfort, mouth tingling |
I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I ...
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I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I started to have a metallic taste in my mouth. Five minutes after that, my lips and tongue started to tingle. Five minutes after that my tongue started to go numb and then a few minutes after that my throat felt sore. Around 3pm, I took two Benadryl. By 5:30pm, my tongue was no longer numb, but my mouth didn't feel right all night. I don't know if this was related, but on Wednesday morning I woke with the start of a migraine. I took something right away and was able to avoid it. I have only had 4-5 migraines in my adult life. I started to feel like I was getting a cold by Friday, but I'm not sure if this is related either.
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| 49 | 2021-03-06 | loss of taste, loss of smell | March 4, 2021 new onset nasal congestion, loss of taste & smell. COVID-19 PCR positive. |
| 49 | 2021-03-07 | lacrimation increased |
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll...
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Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
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| 49 | 2021-03-07 | loss of taste, loss of smell |
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable co...
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Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on right arm on 04Feb2021 at 12:30 (at the age of 49years) at single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure and high cholesterol. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on right arm on 14Jan2021 at 08:00 (at the age of 49years) at single dose for Covid-19 immunization. The patient experienced loss of taste and smell on 05Feb2021 at 18:00. Treatment was received for the adverse events. The events were considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The facility where the most recent COVID-19 vaccine was administered was in a military base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 49 | 2021-03-07 | vision blurred |
Pt. reported feeling lightheaded and dizzy, Headache and blurry vision when trying to text within 10...
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Pt. reported feeling lightheaded and dizzy, Headache and blurry vision when trying to text within 10 minutes of getting dose of vaccine. Patient was transported to ED. HA and blurred vision resolved. Given toradol and zofran. Discharged stable.
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| 49 | 2021-03-07 | swollen tongue |
Received vaccine at 5:00 pm. At 5:10, noticed heavy/fast breathing; at 5:12, tightness in throat; at...
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Received vaccine at 5:00 pm. At 5:10, noticed heavy/fast breathing; at 5:12, tightness in throat; at 5:18, puffy tongue. No medical intervention; symptoms resolved on their own after 30-45 minutes.
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| 49 | 2021-03-08 | thirst |
The employee waited 30 min after the vaccine because she had her Rituxan infusion 10 days prior to t...
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The employee waited 30 min after the vaccine because she had her Rituxan infusion 10 days prior to the vaccine. When walking to her car her throat felt itchy, but she blamed it on the cold weather. During the night she felt excessive thirst and a moderately itchy throat that lasted 2 days post vaccine.
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| 49 | 2021-03-08 | thirst |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | mouth numbness |
No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extrem...
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No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extremities, thick/numb feeling in tongue, coughing. taken to ED and given IV Benadryl and oral prednisone. Given prescription of for prednisone and Zyrtec for home use. At home, shortness of breath with coughing, lightheadedness, numbness/tingling in extremities, itching persisted for the next 5days. Took prednisone as prescribed for 3 days. Did not take allergy medication. Three days later on Thursday 2/22, I fell while going down stairs and suffered a badly sprained ankle. I feel the fall is a result of lingering symptoms of the vaccine.
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| 49 | 2021-03-10 | mouth tingling |
20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical...
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20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical staff gave me 25mg of Benadryl and apple juice. I waited another 15 minutes and I felt tingling in the tongue. Dr observed me Pulse and Bp were low to start and became elevated. I received another 25mg of Benadryl and I was observed for another 20 minutes. I woke up that evening feeling tired. I woke up in a few hours feeling like I was beaten up joint pain and muscle pain. Muscle tremors were worse than normal it was difficult to walk. Low grade fever and headache. This lingered for a few days. I developed mouth sores after days and still had a headache. Arm pain and aches and pains. Total time feeling poorly was 9 days. I visited an allergist on the advice of facility, allergist advised Zyrtec before next dose. Second dose caused similar symptoms with severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal. Instability and fatigue lasted three weeks. Mood swings were unusual.
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| 49 | 2021-03-11 | dry mouth |
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - ...
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About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes. During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline. These subsided - and started again with a couple minutes between each wave. I took a Benadryl once I arrived home - only 2 very minor waves that morning. No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
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| 49 | 2021-03-11 | loss of smell, loss of taste |
Vaccinated 12/20/2020. On 12/21/2020 developed loss of taste/smell, nasal congestion, cough, and ...
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Vaccinated 12/20/2020. On 12/21/2020 developed loss of taste/smell, nasal congestion, cough, and shortness of breath. Positive COVID test.
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| 49 | 2021-03-12 | visual impairment |
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the...
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02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
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| 49 | 2021-03-12 | eye itchiness |
1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions ...
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1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions in the past and was thus observed for 30 minutes following her injection time. 1704 ? Vitals: 99% sp02, 192/101 BP. Patient reported symptoms of itching of face, scalp, eyes, and hands. 25 mg Benadryl given by Observer. Patient placed on continuous sp02 monitor. No SOB, cough, or wheezing at this time. 1710 ? Observers called ED Nurse to let them know we would likely be sending a patient their way. 1715 - Observer was advising patient?s husband to take her to the ED when Coordinators were alerted to situation. contacting ED and allowing patient to transport themselves is not our protocol and Coordinators took control of the situation at this time. 1717 ? 1720 ? Patient moved by wheelchair to private area in the library for further evaluation. Vitals: 99% sp02, 200/119, BP, 90 HR. assessed patient. Rash but not hives are present on her chest. There is mild end-expiratory wheezing consistent with asthma history. No airway edema. No trouble speaking or swallowing. She is mildly diaphoretic but neurologically intact. 1720 ? Rapid response called for transport to ED. Sp02 98 ? 99. 1722 - Patient is starting to have increased wheezing with sp02 holding at 98%. She doesn?t have her inhaler. 1727 ? Rapid response called to say transport is 5 ? 10 minutes away. Patient still on monitor. No visible airway edema. Starting to cough and bilateral upper extremities mildly edematous. She notes her back is itching in addition to chest. 1728 ? After briefly explaining procedure to patient and obtaining verbal consent, 0.3 mg Epi Pen injection given to right lateral thigh. Vitals 192/133 BP, 91 HR, 99% 02. 1731 ? EMS arrives. Itching, wheezing, and cough have improved. Report given to EMS. Patient transported by stretcher to ED. Report had previously been given to ED and updates since then were given to EMS.
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| 49 | 2021-03-12 | lip swelling | At 30 min front lip swelling |
| 49 | 2021-03-12 | mouth numbness |
c/o HA and numbness in lips and tongue 30mins after vaccination. Pt received Benadryl 50mg po, w/ r...
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c/o HA and numbness in lips and tongue 30mins after vaccination. Pt received Benadryl 50mg po, w/ resolved symptoms.
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| 49 | 2021-03-14 | pain in jaw |
Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I w...
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Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I woke with severe pain all over my body. The worst pain was left arm, neck, back, buttocks, calves. Moderate pain throughout the rest of my body, notably my torso and my jaw. I had terrible headaches throughout the day. I was fatigued/exhausted and slept for several hours intermittently throughout the day. By 9PM I started to feel less fatigued, but the pain was very bad in most of my muscles. I felt like my muscles were battered and beaten, bruised and weak. The next day (3/14) I started to have energy, but not a lot, around 11am, and was still very sore, but the pain had subsided, and no more headaches. Today is 3/15, I am still very tired, but wouldn't call it fatigue, rather less energy than I am used to. I have noticed that my back is still very sore, especially the intercostal muscles. My legs and buttocks are still very sore today. I would not call it pain, but definitely notable and uncomfortable soreness.
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| 49 | 2021-03-15 | ringing in ears | Tinnitus in both ears developed about six hours after receiving the vaccine. |
| 49 | 2021-03-15 | loss of smell, loss of taste |
received 2nd dose of Pfizer COVID vaccine 1/11/2021. On 3/1/2021 developed body aches, headache, c...
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received 2nd dose of Pfizer COVID vaccine 1/11/2021. On 3/1/2021 developed body aches, headache, cough, sore throat, rhinorrhea, loss of taste/smell, nausea / emesis
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| 49 | 2021-03-16 | vision blurred |
Shortly after 1st dose of Pfizer Biontech, pt. c/o "tightness of throat, pressure in left cheek and ...
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Shortly after 1st dose of Pfizer Biontech, pt. c/o "tightness of throat, pressure in left cheek and ear, nasal congestion, blurred vision. BP 140/98-77, pulse ox 98%. Was offered & declined Benadryl. Sx's improved in 1 hour at the POD. States sx's completely abated 1 hour after arriving home. Did not seek further tx. Pt. has asthma and takes Brio and an inhaler prn. She has had "a few high BP readings in past" but is not on med.
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| 49 | 2021-03-16 | ear pain, ear discomfort |
That evening, I had body aches and a headache. And a scratchy throat and post nasal drip. Next day...
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That evening, I had body aches and a headache. And a scratchy throat and post nasal drip. Next day, (8th), I had a fever - 100.6 (after I took aspirin); body aches; fatigue; dizziness. And ear pain/pressure. That first week, symptoms didn't go away so I went to Urgent care on Friday January 15. I didn't have any sinus issues or infections. For ear pressure/pain and dizziness - they put me on a MEDROL dose pack. I was taking Sudafed and Mucinex and Claritin for it prior to this to help it. In two days, I went to ENT (1/17) and on 1/18, I got on 6 days of Prednisone and they also put me on Flonase nasal spray which still didn't help the ear pain/pressure/popping and dizziness. I went to February 3 ENT physician because it hadn't helped and he another six days of Prednisone - Eustachian Tube Dysfunction > February - 25. The intermittent dizziness f and ear pain/pressure finally went away (almost 7 weeks later). I still have ear popping even today (which isn't usual for me). I'm still taking Flonase because I have the popping ear problem still.
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| 49 | 2021-03-16 | vision blurred, mouth numbness |
Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first ...
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Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first 30 minutes happened 3 times. Felt like throat was tight when swallowing . Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for 2 hours . went back to Cvs and stayed for a an hour . Felt like swelling of throat for the first night . 2 days had a sore throat , little by little went away. took 3 days to swallow normal. Called her doctor for advice on second short
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| 49 | 2021-03-16 | eye pain, dry mouth |
very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually startin...
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very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.
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| 49 | 2021-03-17 | mouth discomfort, mouth tingling |
intense tingling in lips and tongue about 30 minutes after shot. Lasted for over 18 hours. Took a...
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intense tingling in lips and tongue about 30 minutes after shot. Lasted for over 18 hours. Took a single Benadryl tablet at 5:00pm, monitored blood pressure. Did not seek medical attention. Next morning, lips still burning, no other side affects.
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| 49 | 2021-03-20 | taste impairment | Fever, aches, joint pain, headache, weakness, nausea, aftertaste, indigestion |
| 49 | 2021-03-20 | swelling of eyelid |
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, M...
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I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg. Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
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| 49 | 2021-03-21 | swollen tongue, lip swelling |
Patient had swelling of lip and tongue, followed by shortness of breath/difficulty breathing for abo...
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Patient had swelling of lip and tongue, followed by shortness of breath/difficulty breathing for about 10 minutes, diphenhydramine liquid and 1 dose of epinephrine autoinjector administered, EMS called and assessed patient, no transport to hospital, patient was able to leave on her own at about 9:00am
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| 49 | 2021-03-22 | vision blurred |
3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head p...
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3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head pain. As the day progressed, experienced pain/inflammation in leg muscles and body. Headache worse. Brain fog. Slow to focus eyes.
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| 49 | 2021-03-22 | smell distorsion, taste disorder |
I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I...
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I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I was the only person that could smell it. It was like an antiseptic smell & if you could imagine what that might taste like, that is the best way to describe the strange test I got while eating & drinking. This lasted about a week. Plus, my left arm where I received the injection was sore for about 2 - 3 days, but I suppose that's to be expected.
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| 49 | 2021-03-22 | ringing in ears | Tinnitus. Still ongoing. |
| 49 | 2021-03-22 | lip swelling, mouth tingling |
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fa...
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Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
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| 49 | 2021-03-22 | lip swelling |
bumps in mouth on first day, face turned read on second day and bumps went away, third day lips beca...
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bumps in mouth on first day, face turned read on second day and bumps went away, third day lips became raw and almost wind burned and chapped then fourth and fifth day lips swelled up very large as well as chin and lower face and cheeks. Benadryl, claritin given together as well as epi pen for emergency use.
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| 49 | 2021-03-23 | eye itchiness |
Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hi...
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Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hives on left thumb within 30 minutes of dose.
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| 49 | 2021-03-24 | ringing in ears |
Pfizer BioNTech Covid 19 vaccien Ringing in left ear started 1/27/21 intermittently for a few days ...
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Pfizer BioNTech Covid 19 vaccien Ringing in left ear started 1/27/21 intermittently for a few days and then started ringing nonstop and continues nonstop as of current. Significant vertigo, nausea and occasional headache. ENT appointment scheduled 4/13/2021 with Dr.
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| 49 | 2021-03-24 | mouth numbness | Throat tightness, numbness in the tongue. Benadryl 50mg PO. not getting better after one hour. |
| 49 | 2021-03-24 | feeling of choking, mouth tingling |
Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my enti...
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Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my entire body (different parts) itched on and off for two days. I contacted my primary doctor who had me take zyrtec to alleviate the itch. Walgreens staff DID NOT make anyone stay for 15 minutes after their shots to make sure there were no reactions. They are also NOT giving the second dose until FOUR WEEKS LATER not the recommended THREE. I wish I had known this before I went there - there are so many other facilities that are doing a wonderful job.
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| 49 | 2021-03-24 | mouth tingling |
flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness w...
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flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness went away and the trembling/chattering turned into tingling lips. Hours later, my lips still feel weird. Treatment is nothing - it's not a big deal, I just wanted to report this to be helpful. I will call my doctor if this doesn't go away in a few days.
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| 49 | 2021-03-25 | ringing in ears |
Muscular aches, exhaustion for several days. In the past I?ve had occasional vertigo and that has go...
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Muscular aches, exhaustion for several days. In the past I?ve had occasional vertigo and that has gotten severe since the vaccine shot. Also have been suffering tinnitus since the shot, which I thought was just the sound of my lamps or air filter but it?s worse at night wearing ear plugs. Both conditions have been increasing since the vaccine and it dawned on me this evening that it could be vaccine-related.
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| 49 | 2021-03-25 | mouth tingling |
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ...
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On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
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| 49 | 2021-03-25 | lip swelling |
Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like thi...
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Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like things are worsening. Epinephrine 0.3mg given x 1. VSS. Symptoms improved and patient discharged feeling normal. Left with hoarse voice and HA.
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| 49 | 2021-03-25 | swollen tongue |
Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reactio...
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Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.
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| 49 | 2021-03-25 | swollen tongue, eye swelling, mouth swelling |
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me...
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
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| 49 | 2021-03-26 | lacrimation increased |
Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itc...
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Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itchy from head to toe. Fever of 99.5. Felt like an allergy attack with runny watery eyes and itchy ears. Throat felt itchy and dry.
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| 49 | 2021-03-26 | tongue itchiness |
Patient complaint of throat and tongue itching. BP 152/92 P-73 Sp02 98%. Gave 50mg of Benadryl. M...
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Patient complaint of throat and tongue itching. BP 152/92 P-73 Sp02 98%. Gave 50mg of Benadryl. Monitored patient for 40 minutes, signs and symptoms resolved. Patient discharged in stable condition with spouse driving patient home in private vehicle.
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| 49 | 2021-03-26 | ringing in ears |
headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm p...
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headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm pain as well with both shots. The ear ringing is constant and loud and hasn't stopped since the day after shot 2. The headache seems to come and go.
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| 49 | 2021-03-27 | vision blurred |
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ...
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Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
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| 49 | 2021-03-30 | oropharyngeal discomfort |
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; hear...
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severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-04-06 | taste impairment, double vision |
face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowi...
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face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.
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| 49 | 2021-04-12 | ear discomfort |
pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; short...
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pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
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| 49 | 2021-04-16 | blindness |
Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primar...
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Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primary care doctor for further testing, blood labs, endocrinologist visit and additional labs. Vision care for vision loss.
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| 49 | 2021-04-21 | ear discomfort |
Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore t...
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Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
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| 49 | 2021-04-22 | ear pain |
All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes...
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All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
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| 49 | 2021-04-24 | lacrimation increased, dry eye |
Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pa...
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Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing headache, dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
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| 49 | 2021-04-28 | mouth tingling |
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem...
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This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
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| 49 | 2021-04-30 | eye bleeding |
Burst blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient). ...
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Burst blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 49-years-old via an unspecified route of administration, administered in arm right on 01Apr2021 15:30 (Batch/Lot Number: Fp6955) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included canagliflozin (INVOKANA), metformin and rosuvastatin; taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 (lot number: En6199) at the age of 49-years-old administered on the right arm for covid-19 immunisation. The patient experienced burst blood vessel in left eye on 12Apr2021. No treatment was received for the event. The patient was recovering from the event.
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| 49 | 2021-04-30 | ringing in ears |
idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after th...
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idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after the 2nd Vaccine; tinnitus on my left ear on and off; felt extreme fatigue and tired; This is a spontaneous report from a contactable other healthcare professional (reporting for herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2, via an unspecified route of administration, administered in left arm on 02Feb2021 10:00 A.M. at the age of 49 years old, as a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient had no known allergies and no prior COVID vaccination. The patient was not also tested with COVID post vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 vaccine for COVID-19 immunization and experienced minor headache. On 08Feb2021, the patient reported that she experienced severe headache on her left head for full 3 days after the 2nd Vaccine. The patient had a minor headache when she had the first vaccine, but it lasted only a day and it was mild one. About 1 week after the 2nd vaccine, the patient had a tinnitus on her left ear on and off. She thought it was because she was tired. For some reason after the 2nd shot, the patient felt extreme fatigue and tired. The left ear ringing was happening more frequently and getting loud. The patient went to urgent care and also went to ENT, and there it was found out that she was having an idiopathic sudden hearing loss on left ear. The patient was treated with oral steroid and injection but the hearing sensory was not coming back yet. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on idiopathic sudden hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 49 | 2021-05-03 | oropharyngeal discomfort |
light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure...
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light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-05-04 | ringing in ears |
headache, head spinning, fever, ringing in ears, strange buzzing sound in head, body aches similar...
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headache, head spinning, fever, ringing in ears, strange buzzing sound in head, body aches similar to mild flu. Headaches, head spinning and flu like body aches lasted a few days.
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| 49 | 2021-05-05 | ringing in ears |
Experienced excessive fatigue 6 hrs post vaccination. Not concerned. Following morning noticed an ...
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Experienced excessive fatigue 6 hrs post vaccination. Not concerned. Following morning noticed an increase in tinnitus symptoms. I had longstanding, mild tinnitus, in one ear, however, this was whistling in both ears and an order of magnitude worse.
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| 49 | 2021-05-10 | mouth numbness |
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet;...
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Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-05-11 | ringing in ears, deafness |
Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent vis...
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Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-regnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on 06Apr2021 09:30 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccine facility type was pharmacy/drug store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced tinnitus - 24 hours a day, 7 days a week. that started on 08Apr2021 at 09:00. The patient believed she had hearing loss and was scheduled for ENT visit this week. The patient will have a hearing test (do not know next steps). The outcome of the events was not recovered. Events were reported as non-serious. Information on the batch/lot number has been requested.
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| 49 | 2021-05-11 | dry eye |
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h...
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was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-01-03 | mouth tingling, lip swelling |
1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient r...
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1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient received 25mg diphenhydramine and was observed for 30 mins. Symptoms resolved over 30 minutes.
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| 50 | 2021-01-04 | tongue itchiness, mouth tingling |
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro...
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8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
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| 50 | 2021-01-04 | mouth numbness |
Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and...
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Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)
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| 50 | 2021-01-04 | tongue discomfort, mouth tingling | Burning/ tingling tongue |
| 50 | 2021-01-04 | loss of taste, taste impairment, taste disorder, dry mouth |
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex...
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body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
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| 50 | 2021-01-05 | mouth pain, pain in jaw |
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the...
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. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
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| 50 | 2021-01-05 | lip swelling |
Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a t...
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Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
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| 50 | 2021-01-05 | toothache, mouth pain, burning mouth syndrome |
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ...
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Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
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| 50 | 2021-01-05 | swollen tongue |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-06 | eye pain |
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin...
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Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
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| 50 | 2021-01-06 | dry throat, eye swelling |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | lip swelling |
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 an...
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patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
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| 50 | 2021-01-06 | ringing in ears | tinnitus, face tingling, lymph pain, general muscle pain |
| 50 | 2021-01-07 | pain in jaw |
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty...
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01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
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| 50 | 2021-01-07 | eye irritation |
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ...
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10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
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| 50 | 2021-01-07 | ear discomfort |
Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear,...
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Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear, dizziness.
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| 50 | 2021-01-07 | mouth numbness |
numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a...
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numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.
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| 50 | 2021-01-07 | burning mouth syndrome, tongue discomfort |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-08 | eye pain, eye discomfort |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | tongue discomfort, mouth tingling |
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. Sh...
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Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range. Â Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.
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| 50 | 2021-01-08 | vision blurred | Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills |
| 50 | 2021-01-09 | oropharyngeal discomfort |
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,...
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STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
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| 50 | 2021-01-09 | swollen tongue, lip swelling |
swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 5...
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swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 50 mg of benadryl at 815, at 830 I took zyrtec 10 mg and went to the ER. At 945 they gave me a shot of decahedron and discharged me at 10 30 with prescription for oral steroids, epi pen and instructions to take pepcid, zyrtec twice daily and benadryl as needed.
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| 50 | 2021-01-10 | oropharyngeal discomfort |
Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER...
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Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER visit.
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| 50 | 2021-01-11 | extreme sound sensitivity, sensitivity to light | Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired |
| 50 | 2021-01-11 | mouth numbness, eye pain |
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m...
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Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
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| 50 | 2021-01-11 | oropharyngeal discomfort |
Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol,...
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Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol, and albuterol
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| 50 | 2021-01-11 | taste impairment, mouth tingling, ear itchiness |
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ...
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both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
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| 50 | 2021-01-11 | dry throat |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-12 | swollen tongue |
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi...
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Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
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| 50 | 2021-01-12 | swollen tongue |
Right-sided tongue swelling 13.5 hours after administration of second dose of the vaccine. Resolvin...
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Right-sided tongue swelling 13.5 hours after administration of second dose of the vaccine. Resolving with benadryl and pepcid.
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| 50 | 2021-01-13 | ear discomfort |
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte...
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Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
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| 50 | 2021-01-14 | mouth tingling |
10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing....
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10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing. Is experiencing watering eyes and occasional coughing 10:49- received dose of 25mg diphenhydramine with slight improvement in symptoms, not resolved. 10:52- notes sensation of tingling tongue- Emergency Response Team called 11:02- 2nd dose of 25mg PO diphenhydramine administered Emergency Response Team Staff transports Employee to Emergency Room
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| 50 | 2021-01-14 | feeling of choking |
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient beg...
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Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
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| 50 | 2021-01-14 | mouth tingling |
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ...
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Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
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| 50 | 2021-01-14 | lacrimation increased |
Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee repor...
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Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee reported sensation in throat while swallowing, eyes watering, occasional cough-Denies troubles breathing, denies swelling of lips tongue or throat. Drank water without difficulties 10:49- Provided 25mg of PO liquid diphenhydramine Observed- continued to have symptoms. Emergency Response Team called 10:55- Pt reports some improvement in symptoms- coughing resolved 11:02- Additional 25mh of PO Liquid diphenhydramine provided. Pt was transported to Emergency Room for Evaluation
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| 50 | 2021-01-14 | ringing in ears |
Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Verti...
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Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Vertigo; This is a spontaneous report from a contactable pharmacist. A 50-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscular at arm right on 17Dec2020 13:30 at single dose for COVID-19 immunization at a Workplace clinic. The patient's medical history was reported as none. No known drug allergies. Concomitant medication (received within 2 weeks of vaccination) included ergocalciferol (VIT D). The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that while getting first dose, patient experienced instant "funky lightheadedness, vertigo. Normal tinnitus got louder and oscillating up and down. Next day after first dose (18Dec2020), patient had sinus headache and vertigo, took meclizine and went back to bed. Felt fine when she woke up. The outcome of the events sinus headache and vertigo was recovered on an unspecified date, for the rest of events was unknown. The reporter consider the evens as non-serious.
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| 50 | 2021-01-14 | swollen tongue |
Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp...
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Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp 168-144/100-94 during episode with pulse ox 96%. patient was rosy and flush. Administered 1 epinephrine pen and 50 mg oral diphenhydramine . patient monitored from 3 pm until 530 pm and advised to see primary care provider
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| 50 | 2021-01-14 | eye swelling, eye itchiness |
Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling wors...
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Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling worsening over the 5 days after injection leading to Urgent Care visit.
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| 50 | 2021-01-14 | lip swelling, swollen tongue |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | ringing in ears |
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This ...
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funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
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| 50 | 2021-01-17 | swelling of eyelid | SEVERE SWELLING OF LEFT EYE LID AND MILD SWELLING LEFT SIDE OF HER FACE. REDNESS. |
| 50 | 2021-01-18 | oropharyngeal discomfort, tongue discomfort, mouth numbness |
Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny n...
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Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny nose. I had taken Benadryl and Prednisone before hand because had all above symptoms with first Pfizer shot (EJ1685). The following days I had severe headaches with nausea and dizziness and lethargy as well as diarrhea. Four days later after the shot on the 1/15 I experienced fluid accumulation in the lungs followed by burning sensation on the tongue, numb lips, and a sensation of swelling in the inner lining of the throat. With Benadryl symptoms subsided.
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| 50 | 2021-01-18 | ear pain |
low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthral...
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low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthralgias, myalgias.
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| 50 | 2021-01-19 | eye swelling, lip swelling |
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell...
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Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
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| 50 | 2021-01-19 | dry throat | Fever, headache, chills, dry throat, body aches |
| 50 | 2021-01-19 | mouth numbness |
perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95...
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perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95 mask. Given procedural mask and reported improvement of symptoms. Rapid response contacted. No other intervention
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| 50 | 2021-01-20 | inability to speak |
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy ...
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She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released. ER records note tachycardia at 107 but otherwise normal VS and exam. .
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| 50 | 2021-01-20 | vision blurred |
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ...
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inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-21 | ear discomfort |
On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burn...
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On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burning and when I looked in the mirror saw that they were extremely red, and then saw that my neck was red, pulled my long sleeves up and noticed a rash forming and within 5 minutes had a full blown body rash and redness; I was given a Benadryl and then I drove to the Urgent Care Clinic and was treated with Dexamethasone, and a Pepcid which resolved the rash within 20 minutes .
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| 50 | 2021-01-21 | vision blurred |
Patient experienced dizziness, diaphoresis and blurry vision. Patient was given water, covered with ...
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Patient experienced dizziness, diaphoresis and blurry vision. Patient was given water, covered with a blanket and allowed to lie down. Placed on 2lpm via nasal cannula and monitored via blood pressure cuff. Patient recovered after 30 minutes of observation and was safely released. Follow up later in the afternoon and the next morning were done with patient who stated she was doing very well.
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| 50 | 2021-01-23 | vision blurred |
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tyleno...
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Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tylenol and Ibuprofen.
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| 50 | 2021-01-24 | mouth numbness |
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient...
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1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
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| 50 | 2021-01-24 | dry throat |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-24 | swollen tongue | Itchy face, tongue swelling, face swelling |
| 50 | 2021-01-25 | taste impairment |
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injecti...
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5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore. Redness and swelling dissipated on 4th day and looked like a bruise. About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red. I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
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| 50 | 2021-01-25 | mouth tingling |
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef...
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About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
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| 50 | 2021-01-25 | hearing loss |
The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I ...
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The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I stayed in bed and slept all day. I also noticed that my brain was foggy. The next day I was able to move to the couch, but the headache was still severe with continued brain fog. I called by PCP to see if there was anything that I needed to be doing or taking and she told me that I should start feeling better the next week. The headache remains but is mild. I have memory loss and difficulty concentrating. I am a nurse and over my weekend at work, I had difficulty doing my job because I couldn't keep track of what I was supposed to be doing and had difficulty charting. My coworkers even commented that I seemed "really different", that my memory was poor, I had personality changes (according to one person) and that my standard of care was much less than usual. One person also commented that seemed to not be able to hear her and kept asking her to repeat herself. I find myself having to concentrate harder to see when I am reading or typing something. I missed work on January 14 and 15 because of the mental fogginess and headache. I thought I was doing better, but I realized that I wasn't when I returned to work on January 23 and 24. I have spoken to my PCP on the phone once and am awaiting calls from my PCP and neurologist regarding this event.
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| 50 | 2021-01-25 | ringing in ears |
upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is...
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upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
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| 50 | 2021-01-26 | eye pain |
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa...
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Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
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| 50 | 2021-01-26 | mouth numbness |
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl...
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Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
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| 50 | 2021-01-26 | oropharyngeal discomfort |
Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - S...
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Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - Solu-Medrol, Benadryl and Famotidine Resolution of symptoms after medication administration. Diagnosis - Allergic reaction to COVID-19 vaccine
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| 50 | 2021-01-26 | mouth tingling, lip swelling |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | mouth tingling, lip swelling |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-28 | ringing in ears |
New onset bilateral tinnitus, severe headaches and joint pain. 3 weeks after the injection while th...
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New onset bilateral tinnitus, severe headaches and joint pain. 3 weeks after the injection while the headaches had resolved, the joint pain and tinnitus were unchanged.
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| 50 | 2021-01-28 | ear pain | Stabbing pain in left ear, facial and eye weakness, new onset Bell's Palsy |
| 50 | 2021-01-28 | mouth numbness |
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le...
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pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
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| 50 | 2021-01-31 | loss of taste, loss of smell |
I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very col...
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I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very cold, coughing, headache and diarrhea. 36 hours after the shot I began to notice a loss of taste and smell. 48 hours I was very weak and needed to sleep for the next 3 days. Overall loss of appetite, diarrhea and very bad cough continued for at least 1 week.
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| 50 | 2021-02-01 | ear pain |
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower...
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Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.
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| 50 | 2021-02-01 | mouth numbness, taste impairment, mouth tingling |
Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue;...
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Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
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| 50 | 2021-02-01 | taste impairment, sensitivity to light |
metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache...
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metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache, sensitivity to light
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| 50 | 2021-02-02 | mouth numbness, mouth tingling |
Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm ...
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Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
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| 50 | 2021-02-03 | eye irritation |
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extr...
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Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin. Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
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| 50 | 2021-02-03 | mouth numbness |
perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty ...
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perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty swallowing & breathing; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided), intramuscular in the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to garlic. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. On 23Dec2020 09:45, the patient experienced perioral numbness with HA, Difficulty swallowing and breathing. The patient felt it was likely due to the N95 mask. She was given procedural mask and reported improvement of symptoms. A Rapid response was contacted. No other intervention was done. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The patient has not tested for COVID post vaccination.
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| 50 | 2021-02-04 | mouth tingling, feeling of choking |
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient...
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ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
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| 50 | 2021-02-05 | lacrimation increased |
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, ...
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2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
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| 50 | 2021-02-06 | sensitivity to light |
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then col...
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Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours. Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
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| 50 | 2021-02-07 | blindness |
CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE I WAS ON COMPUTER AND HAD BR...
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CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE I WAS ON COMPUTER AND HAD BRIGHT FLASHES OF LIGHTS THE LOST VISION IN THE EYE ABOUT 2 1/2 HOURS AFTER RECIEVING VACCINE. CRVO IS RARE IN MY AGE WITH NO HEALTH PROBLEMS. SAW ER DOCTOR THAT NIGHT THEN OPTHAMOLOGIST THE NEXT MORNING WHO DIAGNOSED ME. I AM CURREENTLY PRESCRIBED A BABY ASPIRIN AND WILL HAVE TO GET INJECTIONS IN MY EYE WHEN MACULAR EDEMA OCCURS, AN EXPECTED OCCURRENCE WITH A BLOOD CLOT IN THE RETINAL VEIN
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| 50 | 2021-02-07 | eye swelling, eye itchiness | Hives, rash, headache, itchy swollen eyes |
| 50 | 2021-02-07 | loss of taste, loss of smell |
Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or ta...
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Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or taste. Tylenol, fluids Motrin, rest shower and than heated blanket set to high to try and get warm
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| 50 | 2021-02-08 | smell distorsion |
I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day se...
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I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day severe stomach cramps from 10:00 AM to 6:00 PM, no appetite during that time, no diarrhea, the next day head ache, tired, heaviness on my head, tired, this lasted for three days. During the fourth day started perceiving a strange smell on and off, it has been 14 days and still have the smell like someone is smoking a cigar rate while in a toilet pooping. I have never smoke and hate the smell of smoke. This last symptom has been driving me insane. This is the only symptom since vaccine is lingering and is bothersome. My next shot will be on Monday the 15 of February, and I am concern, haven't been able to reach the Health Department to report or make questions, called my physician and she is out of the country, reported to the Medical Assistant who answered the phone. I only took motrin and Tylenol during the six days with the first side effects, have done nothing about the smell that is still there.
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| 50 | 2021-02-09 | mouth itchiness, tongue itchiness |
Patient received first dose of Pfizer COVID vaccine and after 20 minutes complained of tongue as wel...
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Patient received first dose of Pfizer COVID vaccine and after 20 minutes complained of tongue as well as roof of mouth itching. Nurse administered oral diphenhydramine 50 mg x 1 dose
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| 50 | 2021-02-10 | bloodshot eyes |
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare...
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Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
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| 50 | 2021-02-10 | loss of smell, sensitivity to light, eye pain, loss of taste |
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ...
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I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
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| 50 | 2021-02-10 | swollen tongue |
tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the...
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tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events. Information on the lot/ batch number has been requested.
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| 50 | 2021-02-11 | swollen tongue |
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d...
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reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
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| 50 | 2021-02-14 | mouth numbness |
1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight ...
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1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight but she was asthma as well and took her Albuterol which helped. NO chest tightness at this time. Numbness improving.
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| 50 | 2021-02-14 | eye itchiness |
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc...
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She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
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| 50 | 2021-02-15 | visual impairment |
From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/1...
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From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/14, had dizziness, seeing spots in her eyes, lethargy and was sent to to ED and discharged. Generalized itching the next day. All sxs have resolved since yesterday. Scheduled to work on Friday, 1/22. From ED note: 50 yo f c/o mild dizziness and light-headedness today, worse with standing up. No n/v/d/f/c. Describes sx as typical early flu like sx today but slightly worse that her usual feeling from flu vaccines. Received the covid vaccine yesterday and friend experienced same symptoms. Felt "difficulty concentrating at work", which was very busy. No weakness, pre-syncope, numbness, cp, sob. No unsteady gait, vision changes. occ vision spots assoc with standing up. H/o anemia, h/o gastric bypass 2005. Often gets routine labs q 6 months but has not had any yet since COVID.
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| 50 | 2021-02-15 | ringing in ears | Received P vaccine instead of M. C/o ringing in the ears after vaccine |
| 50 | 2021-02-16 | lip swelling, swollen tongue | Flush face chest, swollen checks , lips, tongue, had issues talking |
| 50 | 2021-02-18 | ear pain |
On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling rig...
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On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right. There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face. By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours. I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face. From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding. He said it was Bells Palsy. He prescribed 10 days of prednisone and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face. By the 2nd week I was able to sit up more, but still very tired/fatigued. I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
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| 50 | 2021-02-18 | mouth tingling |
Patient had high anxiety entering into vaccination chair. Talked at length about current data and al...
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Patient had high anxiety entering into vaccination chair. Talked at length about current data and allergy reactions. After about 10 min post dose resident reported feeling dizzy and that jaw "felt weird" . Took patients blood pressure at 11:15am - reading was 184 / mmHg and pulse was 106. Upon further discussion jaw felt "tight" - verified with patient that it did not feel like it was closing, and that roof of mouth was tingling. Benadryl offered, and patient declined. She stated she would like fresh air, and went outside and took a walk with a nurse. Blood pressure rechecked at 11:33am BP was 188 / 111 mmHg pulse 96. Resident states that her normal BP is around 145/90. Automatic BP checked again at 12:51pm was 188 / 112 mmHg and pulse 89. Had checked with pharmacy intern manually and reading was 166/104 mmHg. Patient stated she felt "better" jaw was ok and tingling in mouth was subsiding. Discussed importance of calling her PCP to discuss potential diagnosis of hypertension.
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| 50 | 2021-02-21 | ear discomfort, ear pain |
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni...
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dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
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| 50 | 2021-02-23 | lip swelling, mouth tingling |
SWELLING OF LIPS x 3 different occasions since the second dose. My lips got puffy and tingly, they w...
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SWELLING OF LIPS x 3 different occasions since the second dose. My lips got puffy and tingly, they were red, swollen and very irritated for days after the initial second dose and then again two different occasions during the month of February. Treatment was taking antihistamine when I got home. After the third reaction of lip swelling I called my primary doctor to let him know about my symptoms and he recommended an over the counter anti-histamine, which I am currently taking.
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| 50 | 2021-02-23 | ear pain |
Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regula...
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Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regular to 101F. 20 hrs after vaccination, T100.7F, then persisted up and down for about a week. 2) Musculoskeletal pain to Left side of body: Mainly left upper body. -- 17 hrs after, woke up with severe pain to Lt shoulder and clavicle (thought it was broken somewhere.) The injected site was sore but mild. The Musculoskeletal pain still continues, and the pain comes in various sites, various forms, and in various level. It can be at Left shoulder, scapula, armpit, rib, lumber, hip, knee, and foot. Once in a while, Left ear pain. Mostly Lt shoulder, scapula, armpit, rib lately (today is 0224/2021.) Level changes depends on how it hurts; severe-moderate/shooting and needle pain, moderate/radiating pain, moderate-mild/dull pain, mild/annoying persistent uncomfortable pain. 3) neck and jaw joint stiffness only on left side. Current. 4) Extreme fatigue and brain fog--Extreme fatigue started on the next day and persisted for 3 days, then it became randomly daily. No warning signs given, suddenly feels extremely tired. This fatigue often comes with intermittent confusion. When severe, unable to move while laying. Today is 3rd week from vaccinated and unresolved completely.
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| 50 | 2021-02-24 | mouth tingling, tongue disorder |
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f...
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I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
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| 50 | 2021-02-24 | mouth numbness |
Tongue feels numb. Breathing without difficulties. b/p 150/60 continued to monitor. Refused an...
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Tongue feels numb. Breathing without difficulties. b/p 150/60 continued to monitor. Refused any further treatment. b/p140/80
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| 50 | 2021-02-25 | eye irritation, dry eye, ear swelling, mouth pain |
Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflamm...
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Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
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| 50 | 2021-02-28 | mouth numbness |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-03-02 | eye swelling, lip swelling |
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ...
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"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
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| 50 | 2021-03-02 | ear discomfort, ear pain, hearing loss, extreme sound sensitivity | decrease hearing to rt ear, discomfort related to normal sound , pain from loud and high pitch sound |
| 50 | 2021-03-03 | taste impairment | METAL TASTE IN MOUTH 5 MINS AFTER INJECTION NO TREATMENT |
| 50 | 2021-03-03 | eye pain |
Within approximately 56 hours from 1st injection, I got an intense left eye pain. Went to the ER w...
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Within approximately 56 hours from 1st injection, I got an intense left eye pain. Went to the ER where they flushed it, numbed it, and prescribed drops for conjunctivitis. I had no symptoms prior. Completed treatment and seemed fine. Within 13 hours of second dose (3/3/21 @ 2:00 pm), I woke up with eye pain in the left eye and used part of the remaining drops; thankfully did not get as bad as the first one, so far.
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| 50 | 2021-03-03 | taste impairment, tunnel vision | funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso |
| 50 | 2021-03-04 | mouth tingling | Tingling in lips. Evaluated by EMS-Cleared |
| 50 | 2021-03-04 | swollen tongue |
Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I...
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Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I started to cough. It never progressed beyond that. I felt well enough to leave after the 15 min observation period. When I got home, I took 25mg Benadryl.
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| 50 | 2021-03-05 | loss of taste, loss of smell |
12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss ...
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12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss of taste & smell lasted for 6 hours. Ague & extreme tiredness lasted 48 hours
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| 50 | 2021-03-05 | bloodshot eyes, eye itchiness, lacrimation increased |
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red...
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Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
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| 50 | 2021-03-05 | dry mouth | Chest tightness, shortness of breath, dry mouth. |
| 50 | 2021-03-07 | mouth swelling, mouth tingling | tongue tingling, throat and mouth feels swollen, flushing. Evaluated by EMS-Cleared |
| 50 | 2021-03-09 | taste impairment |
Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat an...
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Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat and metal taste in mouth (both of these have gone). Twitches and mild numbness still happening.
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| 50 | 2021-03-09 | taste impairment |
metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a...
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metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3247, via an unspecified route of administration on 24Feb2021 14:00 at a single dose in the right arm for COVID-19 immunization. Medical history included early breast cancer, metallic taste when receiving chemo last year in 2020. The patient had no allergies to medications, food, or other products. Concomitant medication included anastrozole and calcium carbonate, vitamin D. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste same as experienced when receiving chemo last year and mild pain at injection on 24Feb2021 17:00. No treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested positive for COVID-19 since the vaccination. The outcome of the events was not recovered.
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| 50 | 2021-03-12 | mouth swelling, swollen tongue |
Swollen tongue and mouth a few minutes after injection. Not severe. No trouble breathing. Lasted ...
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Swollen tongue and mouth a few minutes after injection. Not severe. No trouble breathing. Lasted a few hours.
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| 50 | 2021-03-13 | mouth tingling, ear discomfort |
Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given ...
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Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given 50 mg oral Benadryl and monitored for over 30 minutes. Patient has a history of epi pen usage due to history of allergies to sulfa, flaxseed and environmental triggers. She has received flu vaccine in the past with minimal reactions. Given oral benadryl 50mg x 1 and monitored for at least an additional 30 minutes. Per pt on my chart in March: tingling of the tongue was mild. The right ear and right side of my head was intense with pressure and it did feel like it wanted to explode. After the Benadryl it started to subside. It lasted about 50 minutes. The rash were not like hives. The rash was on my neck , arms and face. It lasted about 2 days and was a mild case. Not over body. No fainting, no low grade fever.
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| 50 | 2021-03-13 | mouth tingling, swollen tongue |
The patient was vaccinated at 09:12AM, and began experiencing tongue tingling and swelling on the ri...
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The patient was vaccinated at 09:12AM, and began experiencing tongue tingling and swelling on the right side after 20 minutes. The patient reported that the tingling only lasted about a minute with the swelling occurring after. Vital signs taken at 09:20AM. The patient reported decrease in swelling at 10:18AM - "less swollen, more room." Repeat vital signs at 10:20AM. The patient reported resolution of symptoms and indicated that her tongue felt the same as it did prior to vaccination at 11:23AM.
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| 50 | 2021-03-13 | deafness, ringing in ears |
Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second v...
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Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second vaccine, but I wanted to update as to my experience. I got sick with the first one from about 4ish hours after until the next mid morning maybe? Then I felt bad again that second night. I had my vaccine (second) yesterday at 4 PM, and I felt OK going to bed but had a pretty pitiful night. I woke up at 5 AM and I felt horrible. That felt like someone took a pair of metal cymbals and slammed them together on my head. The tinnitus was strong. I also had body aches and joint pain and felt like I had the flu. I felt a little better around 1 PM, but felt bad again around 330. Now I'm miserable again with terrible body aches and chills (this was at 7:38 PM). I'm sure I will feel better in the morning, just wanted to share my experience." Sadly, since then, I have had tinnitus with a metallic ringing in both ears along with hearing loss. I had some vertigo one day but unsure if this was related. The tinnitus makes me very sad. I am a hospitalist and am happy to have been vaccinated, still. It has been 2 months today, and it remains, unrelenting. It is worse in the morning and at night. The hearing loss is difficult.
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| 50 | 2021-03-13 | taste impairment, mouth tingling |
tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left ...
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tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left side of tongue, one to two hours slighter tingling next to left eye, intermittent for days very strong metallic taste in mouth, subsided to slight metallic taste after a few hours
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| 50 | 2021-03-14 | vision blurred |
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. ...
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Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
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| 50 | 2021-03-14 | tongue disorder, ringing in ears |
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to...
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Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
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| 50 | 2021-03-14 | eye swelling |
Patient was sitting in observation and her daughter noticed the left eye was swollen. She told us th...
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Patient was sitting in observation and her daughter noticed the left eye was swollen. She told us that her mom gets botox and fillers all in her face. She gets the hyaluronic acid filler apriline. She declined treatment and felt fine otherwise. She will contact her doctor.
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| 50 | 2021-03-15 | mouth tingling, mouth numbness, lip swelling |
15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I...
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15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I got up an started walking I felt slightly unbalanced. 15minutes later I felt like my lips were swelling and my throat felt tight. On route to the emergency room my lips , tongue and mouth felt numb and tingling. I arrived at ER at 0930 and was given IV Benadryl and prednisone by mouth by ER Dr.
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| 50 | 2021-03-15 | mouth tingling, swelling around the eyes |
20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Pati...
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20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Patient mildly swollen around eyes. VS Stable. IM Benadryl 50MG administered to right deltoid. O2 at 2L per NC administered. Improved for 10 minutes and then tingling and swelling returned. C/O of feeling lightheaded. Medicated with Epi pen to left thigh. Patient improved/stable and was sent via EMS to hospital for evaluation and treatment.
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| 50 | 2021-03-15 | taste disorder |
After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also fe...
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After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also felt it go into my body like a warm rush throughout. I got a little light headed.
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| 50 | 2021-03-16 | eye discomfort, bloodshot eyes, eye pain, sensitivity to light |
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she lo...
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Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved. On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid. She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
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| 50 | 2021-03-16 | bloodshot eyes |
RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY ...
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RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY RED. PATIENTS DID NOT SHOW ANY SIGH OF SWELLING AND WAS ABLE TO BREATH. AFTER REASSES OF THE SITUATUION, PROCEED TO INJECT DIPHENHYDRAMINE 50MG/ML VIAL. PROCEED TO CALL 911, WHEN THE PARAMEDICS ARRIVED, VITAL SIGNS WERE TAKEN. AFTER 15 MINUTES OF THE ADMINISTRATION ALL RASH AND RED IN HER SKIN STARTED TO IMPROVISED. PATIENTS WAS OBSERVED FOR 30 MORE MINUTES AND THE PARAMEDICS PROCEED TO DISCHARGE HER HOME.
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| 50 | 2021-03-17 | tongue discomfort, loss of smell, loss of taste |
1st Covid vaccine 12/19/20 Pfizer EH9899 @ 0930 2nd Covid vaccine 1/9/2021 Pfizer EL3246 @ 0930 2/26...
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1st Covid vaccine 12/19/20 Pfizer EH9899 @ 0930 2nd Covid vaccine 1/9/2021 Pfizer EL3246 @ 0930 2/26 Covid symptoms 3/2 tested positive for Covid, lost taste/smell, had covid tongue with ulcers in mouth - seeking medical attention
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| 50 | 2021-03-17 | tongue discomfort, taste disorder, smell distorsion, ringing in ears |
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ...
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I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
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| 50 | 2021-03-17 | mouth tingling |
Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:...
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Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:00 122/86 HR 88 RR20 SpO2 99% 6:00 Benadryl 25 mg given by mouth, patient stated relief after 5 minutes, no SOB, no c/o of chest tightness, no swelling noted prior to medication administration, lungs clear to auscultation.
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| 50 | 2021-03-17 | mouth tingling |
Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the p...
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Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the pharmacy light headed, flushed, and claimed mouth, lips and tongue were tingling. No signs of facial swelling. Nurse practitioner attached to the pharmacy examined the patient before sending her home in her husband's care.
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| 50 | 2021-03-17 | ringing in ears |
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Ac...
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Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears. Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
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| 50 | 2021-03-18 | mouth tingling, lip swelling |
Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of righ...
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Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of right lower lip. Pt. received Benadryl 50 mg IM. Tingling resolved after 15 minutes. Pt. felt fully recovered at that time, and later did not have any systemic side effects from the Covid vaccine. She admits to feeling anxious with injections and venipuncture.
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| 50 | 2021-03-18 | pain in jaw, eye itchiness |
Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it pa...
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Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it passed within another 30 minutes. A few hours later, pain in upper arm got pretty intense. Then around midnight, the pain in my upper arm had grown so severe that it was spreading into my shoulder and neck. By 2:00 a.m., I woke up in sever pain in my face, not able to open my mouth because my jaw hurt so much. I went back to sleepI was not able to open my mouth until I repeatedly coaxed it open, around 8:00 a.m. By 10:00 a.m., my eyes itched like crazy and were red. My jaw getting stuck shut and my eyes itching insanely are why I'm completing this form.
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| 50 | 2021-03-18 | taste impairment | Strong metallic taste in mouth |
| 50 | 2021-03-18 | mouth tingling |
Was waiting 30 minutes due to previous anaphylaxis and tongue started to feel tingly, we administere...
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Was waiting 30 minutes due to previous anaphylaxis and tongue started to feel tingly, we administered 50mg of benadryl generic and held for 2 hour observation. No sequelae.
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| 50 | 2021-03-19 | tongue itchiness |
10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies sho...
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10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies shortness of breath, difficulty breathing throughout episode, observed unlabored breathing, appropriate verbal responses
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| 50 | 2021-03-21 | taste impairment |
Patient stated " bad taste in mouth" denied trouble swallowing several times. All resolved after 2-3...
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Patient stated " bad taste in mouth" denied trouble swallowing several times. All resolved after 2-3 minutes
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| 50 | 2021-03-21 | ringing in ears |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-03-21 | swollen tongue |
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor...
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collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
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| 50 | 2021-03-22 | taste impairment, mouth tingling | Facial flushing, trouble swallowing, metallic taste, lip tingling |
| 50 | 2021-03-22 | eye swelling, ear pain |
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn...
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On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
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| 50 | 2021-03-22 | tongue itchiness, mouth tingling |
Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After...
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Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After bringing patient to UC patient felt itching of tongue, feeling like throat is swelling, shortness of breath, dizziness, slurred speech, loss of consciousness, and chest heaviness.
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| 50 | 2021-03-22 | feeling of choking |
Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficu...
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Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficulty swallowing and hives began to appear on chest and arms. I was given Benadryl through IV about 10:45. I was taken by ambulance to hospital and remained there for about an hour and a half until symptoms subsided
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| 50 | 2021-03-23 | tongue disorder |
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai...
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Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
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| 50 | 2021-03-23 | ringing in ears |
Tinnitus in left ear. Started about 10 days after 1st dose. It's progressively getting worse. I rec...
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Tinnitus in left ear. Started about 10 days after 1st dose. It's progressively getting worse. I received my 2nd dose on 3/17
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| 50 | 2021-03-23 | dry eye |
Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in...
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Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in throat with light coughing.
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| 50 | 2021-03-23 | smell distorsion | Weird or changed sense of smell Patient reporting smells which are non existent or are wrong |
| 50 | 2021-03-24 | mouth discomfort |
11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingli...
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11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingling on rt side of head over next few hours ( I wouldn't call this a headache) 4pm- roof of mouth burning 10pm - went to sleep but only one side of head felt like fire/ice along with mouth 7am - upper body and head feels like on fire/ice Never had a fever
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| 50 | 2021-03-24 | thirst |
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot ...
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Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes. I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
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| 50 | 2021-03-24 | loss of smell, loss of taste |
Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness,...
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Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness, chest pressure, shortness of breath, extreme tiredness. Everyday passing I was feeling worse, adding radical mood swings. Today March the 25/2021 I am still with taste loss, with chills, with the mood swings (the ones that had me partially hospitalized), the skin pigmentation changes is not the same, and tiredness.
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| 50 | 2021-03-24 | ringing in ears |
Vaccine administered at 1425, patient did not have any tinnitus at time of vaccine. At 1730 she bega...
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Vaccine administered at 1425, patient did not have any tinnitus at time of vaccine. At 1730 she began to experience bilateral pulsatile tinnitus that has been consistent to this moment. She reports it as high-pitched ringing like turning on an old TV. Around that same time she began to experience a bilateral throbbing headache at her temples. The headache resolved when she went to sleep. The tinnitus has been persistent.
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| 50 | 2021-03-24 | lip swelling |
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen...
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evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
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| 50 | 2021-03-25 | ringing in ears |
Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, ...
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Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, dizziness, ringing of ears
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| 50 | 2021-03-26 | taste disorder |
Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mou...
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Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mouth
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| 50 | 2021-03-26 | mouth numbness |
Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical con...
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Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical consultation recommended transport BP 104/80, HR 60, SpO2 100%, RR 12 EMT arrived 10:45am, pt transported.
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| 50 | 2021-03-27 | tongue discomfort, loss of taste |
45 hours after 1st vaccination, had a burning sensation on the tongue as if I drank a very hot drink...
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45 hours after 1st vaccination, had a burning sensation on the tongue as if I drank a very hot drink and burned my tongue. I had lost my sense of taste after that. I took a benadryl, and then next morning my sense of taste had returned. My sense of smell was never affected.
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| 50 | 2021-03-27 | taste impairment, smell distorsion |
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell....
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For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
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| 50 | 2021-03-27 | oropharyngeal discomfort |
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod...
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Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
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| 50 | 2021-03-27 | mouth numbness |
SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP...
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SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP 130/84, HR 64; breath sounds clear. Medics on site at 0932. Signed out AMA.
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| 50 | 2021-03-27 | ringing in ears, ear discomfort |
Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in e...
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Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in ears. Ringing ended day of shot. Wrist hurt for a day. Arm still hurts as of now
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| 50 | 2021-03-28 | ringing in ears, ear pain, ear discomfort, deafness, hearing loss |
On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constan...
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On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; has decreased hearing/decreased hearing of lower register; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), via an unspecified route of administration administered in left arm in the hospital on 08Jan2021 07:30 as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had unspecified medical history and concomitant medications in two weeks. The patient had no known allergies. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730) administered in left arm on 18Dec2020 at 06:30 PM for COVID-19 immunisation. On 16Jan2021, both ears were clogged but patient couldn't hear well out of left ear and there was a constant hum in it on 16Jan2021 at 06:00 AM. On 17Jan2021, the patient had pain in left ear but it went away. Her left ear still was clogged, has constant hum and has decreased hearing on 17Jan2021. Right ear hearing was always fine and clogged feeling went away in two weeks. The patient saw ear, nose, and throat (ENT) on 19Jan2021, patient was started on steroids. The patient had magnetic resonance imaging (MRI)and several types of hearing tests on 19Jan2021. MRI was normal. Hearing tests showed decreased hearing of lower register. One doctor thought she should mention it since it happened within 8 days of receiving her second vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which includes MRI, steroids, and hearing test. The patient recovered from ear pain on an unspecified date while outcome of the rest of the events was not yet recovered.; Sender's Comments: Based on the information provided, and on plausible temporal association, the Company assessed that a reasonable possibility could not be completely excluded that the reported event Hearing loss (both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it) was related to the PFIZER-BIONTECH COVID-19 VACCINE. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 50 | 2021-04-07 | ear pain, vision blurred |
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac...
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She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
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| 50 | 2021-04-12 | swollen tongue |
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ...
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pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
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| 50 | 2021-04-14 | taste impairment |
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho...
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blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
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| 50 | 2021-04-15 | pain in jaw |
Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics eva...
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Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics evaluated the patient on-site. The patient was hypertensive (229/129). EKG demonstrated NSR, rate 85 bpm, no ST elevation. Paramedics transported the patient to Emergency Department. In the ED, the patient developed centralized chest pain, diaphoresis, and right jaw pain, but denies shortness of breath, nausea/vomiting, focal weakness, fever or chills. The patient remained hypertensive (184/85). Physician administered 325mg PO Aspirin, 0.2mg PO Clonidine, and 1 inch topical Nitroglycerin. The labs and imaging did not present evidence of myocardial infarct or intracranial hemorrhage. Due to symptoms on presentation, the patient was admitted to rule out ACS. Upon admission, the patient stated the chest pain "comes and goes", but is not currently having any chest discomfort. Admitting physician administered 5mg PO Amlodipine, 5mg PO Lisinopril, labetalol 10mg IV, and prophylactic Lovenox. As of 4/16, the patient had not been discharged, but their hypertensive urgency and chest pain have resolved and will be treated outpatient. Internist planning patient's discharge.
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| 50 | 2021-04-15 | swollen tongue |
Woke at 4 am with a the right side of my tongue swollen; This is a spontaneous report from a contact...
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Woke at 4 am with a the right side of my tongue swollen; This is a spontaneous report from a contactable 50-year-old non-pregnant female consumer reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318, Expiration date: unknown) via an unspecified route of administration on Left arm on 02Feb2021 at 20.45 at single dose for COVID-19 Immunization. The patient medical history included thyroid disease and Allergies to Augmentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication included Levothyroxine sodium (88mcg). On 03Feb2021 04:00 am, the patient waited for 15 minutes required and did not feel anything, patient went home, went to bed. Woke at 4 am with a the right side of my tongue swollen. The patient did not receive any treatment. The outcome for event was recovering.
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| 50 | 2021-04-15 | ringing in ears |
severe tinnitus onset at 35 hours (permanent and continious), chills started at 30 hours and lasted...
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severe tinnitus onset at 35 hours (permanent and continious), chills started at 30 hours and lasted 6 hours
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| 50 | 2021-04-16 | double vision |
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi...
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Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
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| 50 | 2021-04-20 | ringing in ears |
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus...
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hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-04-23 | loss of taste, loss of smell |
Lost sense of taste and smell; Lost sense of taste and smell; This is a spontaneous report from a co...
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Lost sense of taste and smell; Lost sense of taste and smell; This is a spontaneous report from a contactable other HCP (patient herself). An 50-year-old female patient non pregnant)received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:EN6201 and expiration date: unknown) via intramuscular route of administration in left arm on 11Feb2021 at 09:00 AM as single dose for COVID-19 immunisation. The medical history included Depression and allergy to cephalosporins. Concomitant medications were not reported. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 11Feb2021 at 19:00, the patient experienced lost sense of taste and smell. The patient did not take any corrective treatment for the adverse event. The outcome of the events was not recovered.
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| 50 | 2021-04-24 | ear discomfort, ringing in ears, extreme sound sensitivity, ear pain |
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out...
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hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
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| 50 | 2021-04-27 | ear discomfort, ear pain, ringing in ears, deafness |
Fullness in ear and headache that led to ear pain and ringing and now told have hearing loss and con...
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Fullness in ear and headache that led to ear pain and ringing and now told have hearing loss and constant ringing
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| 50 | 2021-04-27 | ringing in ears |
severe tinnitus/tinnitus was reported as worsened; This is a spontaneous report from a contactable o...
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severe tinnitus/tinnitus was reported as worsened; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left upper arm on 19Mar2021 (batch/lot number: EN6207; expiration date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing intermittent tinnitus - she has a history of noise exposure and intermittent tinnitus in the past but was certainly unremarkable, she shrunk before the vaccine - she was five seven her whole life and then thinks she was only five six. Family history included hearing loss in her mother, grandmother, and uncle but that was with advanced age. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 26Feb2021 via injection in her left upper arm (lot number: E and then either I or 1 9266; expiration date unknown) for COVID-19 immunisation. The patient experienced severe tinnitus on Mar2021, tinnitus was reported as worsened. She received the second dose of the Covid vaccine on 19Mar2021 and reported a day or two later, she started experiencing tinnitus. She stated that she has been on and off steroids for the tinnitus. She asked if there has been a correlation identified between the vaccine and tinnitus. She asked was this a side effect of the vaccine. She was asking for any information such as studies, articles, awareness and frequency, regarding tinnitus being experienced after the vaccine. She was calling about the COVID 19 vaccine. She stated she was formally a retired audiologist she was calling because she was wondering what information Pfizer has about the onset of tinnitus. She stated after the second vaccine, she has developed significant tinnitus and as an audiologist she has trained people about tinnitus. She asked was this a symptom of the vaccine. She stated she knows tinnitus was a side effect of the COVID virus but was unsure if it was a side effect of the vaccine. She stated as a matter of fact she went to the national adverse reaction to report her reaction but not the particular Pfizer website. She stated she turns 51 next week and was currently 50. She stated she was five six as she has shrunk. She clarified she shrunk before the vaccine and stated she was five seven her whole life and then thinks she was only five six. She stated her doctor does not know she has this side effect. She stated she was going to see an ear nose throat friend but she was waiting. Severe tinnitus: She stated this started between 1 and 2 days after she received the vaccine which was on 19Mar2021 so either 20Mar2021 or 21Mar2021. She stated it may have got worse she had taken a short round of steroids and the tinnitus got better after the first two days and then the tinnitus returned and had no response to the steroids and she has done this twice. She stated the first two days of steroid usage she feels relief then the tinnitus comes back and she said to heck with it and stopped the steroid. She stated the tinnitus was a constant bilateral high frequency pure tone just very high pitch. She stated this was medically significant because it was a significant finding but not life-threatening. First dose was an injection in her left upper arm and received on 26Feb2021 unknown NDC number and expiry date. She stated the lot number was E and then either I or 1 9266. She stated it was actually not her turn in to get the vaccine but School System had extra doses and opened it up to anyone and everyone not just 1A or 1B. She stated she was 50 with no medical significant comorbidities other than arthritis and since the vaccine was opened up to the general public she was also eligible to get the second dose. She stated she believes the COVID 19 vaccine was related to the severe tinnitus because the onset was immediate and she has had tinnitus from other noise exposure but this was very different and not intermittent and does not come and go it was a different pitch too. She stated there has been no changes, no medication changes so everything else remained steady almost immediately after the vaccine her ears started ringing and she sort of ignored it and her ears were screaming loud a significant very loud even in the presence of background noise just a constant high pitch noise. She stated the tinnitus was impacted only 2 days from the steroids and then no impact after. She stated she considered taking a third dose and was still doing experiments. She stated was this something Pfizer was aware of and was there any information about monitoring people. She stated she knows there has not been a vaccine for that long and there may not be long term resolution but she wanted to report and ask what information Pfizer may already have. She stated the first steroid she started approximately 9 days after the onset and she had Medrol left over from her knee. She clarified the name as Medrol dose packs. She stated she thinks it was a 6, 5, 4, 3, 2, 1 Medrol dose pack that she had left over and she was able to set a series of 4, 3, 2, 2, and 1 but she threw packaging away and it was not a current medication as it was dated a couple years ago but she figured she would see if it would work and the first couple days it did but then not so much. Medrol dose packs unknown manufacturer, NDC number, lot number, expiry date. She stated moving forward her husband was a doctor and wrote Prednisone 10 mg and she was supposed to take 30 mg twice a day for 10 days and she took 30 mg once a day since she did not read the bottle and so she took 30 mg once a day for 5 days. She stated the same thing happened the first two days resolved and then nothing. Prednisone unknown manufacturer, NDC number, lot number, expiry date. She stated so she was actually considering taking 60 mg for 10 days and try to hit the tinnitus to see if she has an impact. She stated her concern/whole point to take the vaccine was to get antibodies and the body can recognize it but now a week and 2 weeks out she has taken a steroid which was suppressing her immune system and what does that do to the immune system. She stated the tinnitus was significant and she does not have a quiet moment and it was a cruel injustice as she used to train people and spent hours and hours counseling and now she was experiencing it. She stated it was significant enough to call and see if there was anything Pfizer knows more. She stated the first dose was given at 12:30 to 13:00 and the second dose was around 11:45 to 12:00. The adverse event did not require a visit to the emergency room and physician's office. No prior vaccinations (within 4 weeks). The outcome of the event was not recovered.
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| 50 | 2021-05-03 | thirst, vision blurred, dry throat |
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do...
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fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
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| 50 | 2021-05-10 | ringing in ears |
24/7 RINGING IN BOTH OF MY EARS. I NEVER HAD ANY ISSUES AT ALL WITH MY EARS BEFORE THE VACINNE AND N...
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24/7 RINGING IN BOTH OF MY EARS. I NEVER HAD ANY ISSUES AT ALL WITH MY EARS BEFORE THE VACINNE AND NOW I HAVE A CONTSTANT RINGING IN BOTH OF MY EARS. IT IS SO OVERWHELMING AND I AM BESIDES MYSELF
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| 51 | 2020-12-31 | eye itchiness, lip itchiness | ITCHING OF EYES AND LIPS. 97.6, 130/76, 81. 25MG BENADRYL GIVEN PO. 0909 STATES NO MORE S/S PER PT. |
| 51 | 2021-01-03 | ear pain, ear discomfort | Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection |
| 51 | 2021-01-04 | taste disorder, taste impairment |
Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist. A 51-yea...
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Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist. A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 28Dec2020 at 03:15 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at workplace clinic, age at vaccination was 51-years-old (reported also as 49-years-old, to be clarified). No other vaccine was received in four weeks. Medical history included thryoid disease, and current tx for pulmonary embolism (PE, 3months). Concomitant medications included levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS). On 28Dec2020 at 03:15 PM, the patient experienced taste alteration - funny taste upon injection. Transient. Lasted 10 seconds or so. The event was reported as non-serious. Outcome of the event was recovered on 28Dec2020. No treatment was received for the event. Information on the lot/batch number has been requested.
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| 51 | 2021-01-04 | mouth tingling, mouth numbness, lip swelling |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | mouth numbness, mouth itchiness |
numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spon...
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numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685), intramuscular on the left arm on Dec2020 at single dose for COVID-19 immunisation. Medical history included hypertension and GERD. Concomitant medication included metoprolol, dexlansoprazole, ondansetron and propranolol. The patient previously took gadolinium and midazolam and experienced known allergies: gadolinium and midazolam. The patient experienced numbness and itching in the roof of mouth on Dec2020. Patient received BENADRYL as treatment. The outcome of the events was recovering.
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| 51 | 2021-01-04 | mouth numbness |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-05 | mouth tingling |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-05 | mouth tingling |
COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EME...
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COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EMERGENCY DEPT GAVE DECADRON
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| 51 | 2021-01-05 | swelling around the eyes, eye swelling |
Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes start...
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Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Swelling around mouth; Aching in my mid back; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Batch/Lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included montelukast, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); colecalciferol (vitamin D), and bumetanide (BUMEX). The nurse stated that she got the Pfizer COVID Vaccine yesterday (28Dec2020) and she didn't know if she should report the side effects but she didn't yesterday and she was going to today (29Dec2020). It didn't happen right away, it was like throughout the day, her eyes started swelling around them, she had swelling around her mouth, she still has it actually. She didn't have any breathing issues but there was a lot of aching in her mid back which was gone now, the aching part, but it was the swelling that concerned her. They were around her eye, the left one. She had a question herself though because this was just her first vaccine. She meant it wasn't bad enough that she had breathing issues because she monitored it and it's already in there now. She asks if it would it be okay to get the next one. As treatment, the patient took Tylenol and a Benadryl. The patient also mentioned that she has been extremely tired too. What she meant was she was sitting at her desk at work yesterday and she was nodding off. According to her, it was just offered through work and they went to a hospital to get it. The patient said that she did not have to seek medical treatment for it, so it was not like life threatening. When clarified if the swelling around eyes was still there, the patient stated that it was not as prominent, it was more around the eyes it's worse. She further stated that it has improved, she was still tired but the swelling had improved. The patient was also asked regarding the route of administration and she stated that she believes it was long enough to be, it looked like IM, she was not sure. It might have been a SubQ but she means it wasn't like a huge long needle but it wasn't like the real short ones either. Outcome of the events "Eyes started swelling, around my eye the left one, it is more around the eyes it's worse", "Swelling around mouth", "Aching in my mid back", was recovering/resolving; for the event 'Fatigue' was not recovered, while for 'Somnolence' was unknown. Causality assessment of the reporter between the events 'eye swelling', 'swelling around mouth', 'aching in my mid back', and 'I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of' and BNT162B2 was reported as related.
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| 51 | 2021-01-06 | oropharyngeal discomfort |
Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes ...
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Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes longer than normal as a precaution, due to her allergies. Patient continued to moniter her oxygenation saturation and did not report a drop in oxygen saturation, however, she reported a funny feeling in her throat, difficulty swallowing and shortness of breath. She was escorted to the emergency department via wheelchair for further observation and treatment.
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| 51 | 2021-01-07 | pain in jaw |
I started few hours later started feeling thought it was stress. The next morning around 9am high mo...
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I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
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| 51 | 2021-01-07 | ringing in ears |
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine...
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Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
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| 51 | 2021-01-08 | dry mouth |
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ...
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After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
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| 51 | 2021-01-08 | lip swelling | lip swelling, facial hives/erythema, burning |
| 51 | 2021-01-09 | eye pain, loss of taste |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-09 | eye swelling |
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b...
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Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
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| 51 | 2021-01-09 | mouth tingling, tongue discomfort |
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h...
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Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
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| 51 | 2021-01-11 | lip swelling, tongue disorder |
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro ...
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"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
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| 51 | 2021-01-11 | eye itchiness |
1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as i...
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1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as injection, 1648 itching inner eyes, monitoring patient another 15 minutes, 1703 no increase in itching, "not any different, not progressing", denies rash, patient left after discussing with NP.
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| 51 | 2021-01-11 | mouth numbness |
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy...
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Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
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| 51 | 2021-01-11 | toothache, mouth pain | Nausea, body aches, dizziness, mouth/tooth pain |
| 51 | 2021-01-11 | feeling of choking |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-12 | loss of smell, ear pain | 1/3/21 Sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain |
| 51 | 2021-01-12 | loss of smell, ear pain | 1/3/21 sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain |
| 51 | 2021-01-12 | eye swelling |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-12 | tongue discomfort, swollen tongue |
I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficul...
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I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficulty swallowing, no resp issue and no rash. I took 25 of Benadryl and went about my evening. Tuesday around 12:00 I had that same sensation but a little stronger, I would call it a tongue swelling but no resp issues or swallowing problems. I called my PCP and he recommended me to take Zyrtec (which I take 1 daily) BID and Benadryl prn. I took 3 doses of Benadryl Tuesday and a Zyrtec Tuesday night and one Wednesday and around 8:15 had the same sensation, tongue swelling but milder. I immediately took 50 mg of Benadryl and called my Dr again and he recommended a steroid pack and Benadryl prn and to not take the 2nd dose.
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| 51 | 2021-01-12 | taste impairment | Scratchy throat and metallic taste in mouth 10 min following injection |
| 51 | 2021-01-12 | mouth tingling |
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea...
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Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
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| 51 | 2021-01-13 | pain in jaw |
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g...
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Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
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| 51 | 2021-01-13 | double vision |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-13 | feeling of choking, mouth tingling, mouth itchiness, eye itchiness |
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea...
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Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
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| 51 | 2021-01-14 | pain in jaw, ear pain |
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syn...
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Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after. Also developed right ear pain and jaw pain, which is still present. At the same time my right side of my face was numb which lasted a couple days.
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| 51 | 2021-01-14 | feeling of choking |
Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and ...
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Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and was transferred to urgent care for closer monitoring. She did not experience any dyspnea, and vital signs remained stable until she was cleared to discharge. No other complications noted during the 2 hours patient was observed in urgent care.
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| 51 | 2021-01-14 | swollen tongue |
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re...
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Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
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| 51 | 2021-01-14 | eye swelling |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-14 | eye irritation |
Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my...
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Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my eyes; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 03:45 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021, at 05:00 AM, the patient experienced shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes. Treatment received for the events included an inhaler and acetaminophen (TYLENOL). The outcome of the events shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 51 | 2021-01-14 | tongue itchiness |
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness...
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Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
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| 51 | 2021-01-14 | eye irritation, eye itchiness | body itching, eye itching and irritation, body warm, chest tightness, bradycardia |
| 51 | 2021-01-14 | eye irritation, eye itchiness | body itching, eye itching and irritation, body warmth, chest tightness, bradycardia |
| 51 | 2021-01-16 | mouth tingling |
01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headac...
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01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headache 5/10. She took 1000mg Tylenol. Given history of allergies, I gave her 50mg oral diphenhydramine ? liquid. She also took an Ativan 1mg. She was nervous and upset, but no further reaction except ?tingly tongue?. No rash, examined arms, torso, face, lips. 12:15pm BP 152/82, admitted to some anxiety 12:30 ?feels good?, still some tongue tingling 12:36 BP 140/80 tongue/mouth nothing remarkable I advised her not to drive and sister came to pick her up at 1:30. No further incidents I advised her to talk to her dr about 2nd vaccine and consider an allergist due to prior allergies.
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| 51 | 2021-01-17 | sensitivity to light |
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ...
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BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
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| 51 | 2021-01-17 | eye pain |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-17 | mouth tingling |
Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue ti...
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Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue tingling. Started having symptoms a couple of hours after 2 dose of vaccine. Feels like nerves are burning in these areas. Intense headache 24 hrs after shot. Took Tylenol 500 mg with no relief. Took naproxen 550 mg Tuesday night around 10 pm. Resolved headache but not burning sensation around mucus membranes. Got progressively worse. Saw MD on Friday who did pelvic exam. Confirmed vaginitis. Prescribed Medrol dosepak, refresh vaginal lubricant and topical desitin. Currently on day 4 on Medrol dospak with some relief. Burning sensation now comes and goes and is not constant. Again, the burning sensation feels like the nerves in the areas of mucus membranes are inflamed.
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| 51 | 2021-01-17 | mouth tingling | Tight throat, thick tongue |
| 51 | 2021-01-18 | sensitivity to light |
Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old...
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Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 18Dec2020 (19:15) at a single dose on the left arm for COVID-19 immunization at the hospital. Medical history included allergic rhinitis and cashew allergy. Concomitant medications included fexofenadine, ergocalciferol (VIT D) and cyanocobalamin (VITAMIN B12). On 06Jan2021 (17:45), the patient had mild photophobia within 5 to 10 minutes of the first dose of vaccination. The patient did not recognize the symptom at the time. The patient had self-administered over-the-counter (OTC) oral analgesics as treatment for the event. The outcome of the event, mild photophobia, was recovering. The patient did not have COVID-19 prior to the vaccination, and had not been tested positive for COVID-19 since the vaccination. Information regarding lot/batch number has been requested.
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| 51 | 2021-01-18 | thirst | Pain at injection site, diarrhea, loss of appetite, thirst, joint pains, fatigue, chills |
| 51 | 2021-01-18 | mouth tingling |
Patient expressed burning sensation in throat / tingling on tip of tongue shortly after vaccine. Wa...
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Patient expressed burning sensation in throat / tingling on tip of tongue shortly after vaccine. Was evaluated by MD, taken for observation. Dispo was to home.
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| 51 | 2021-01-18 | oropharyngeal discomfort |
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit i...
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Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
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| 51 | 2021-01-18 | mouth tingling | Tingling of Lips and face |
| 51 | 2021-01-19 | pain in jaw |
Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by after...
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Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by afternoon of 1/19/21. Arm pain and body aches resolved around same time. Significant left jaw pain which began evening of 1/19/21 and continue into 1/20/21. All symptoms alleviated by ibuprofen.
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| 51 | 2021-01-19 | taste impairment |
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday mornin...
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immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
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| 51 | 2021-01-20 | ear pain |
Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) bod...
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Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy. Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity. The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 51 | 2021-01-20 | taste disorder |
Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis...
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Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis from the waist up starting 1/17/21 and changes in her taste with no loss of taste or smell.
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| 51 | 2021-01-20 | taste disorder |
Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/...
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Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/21 she started to have itching from the waist up and she is taking Zyrtec. She has also notice some taste changes but no loss of taste or smell.
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| 51 | 2021-01-20 | eye pain, loss of taste |
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre...
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feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
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| 51 | 2021-01-21 | eye irritation |
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl...
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An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
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| 51 | 2021-01-21 | loss of smell |
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work...
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I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
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| 51 | 2021-01-21 | mouth numbness | Minor Face and Throat swelling. Irregular eye lid movement. Lips num and felt twisted. |
| 51 | 2021-01-21 | lip itchiness |
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it...
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Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
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| 51 | 2021-01-24 | lip swelling |
Swelling above upper lip where I have derma filler. Very minor but still noticeable the day after th...
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Swelling above upper lip where I have derma filler. Very minor but still noticeable the day after the vaccine injection.
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| 51 | 2021-01-24 | swollen tongue |
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir...
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Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
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| 51 | 2021-01-24 | ringing in ears |
n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immu...
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n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immunization was administered too high on arm/shoulder. 1/25 pt is to get dose #2 this week and concerned re: still some numbness but also some ringing in the ear. Tells staff has had some ringing in the ear previous to vaccine mostly at night- this has now intensified to where she is also hearing it during the day. She has d/w her PCP- she is very unsure if she should get vaccine #2 or not.
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| 51 | 2021-01-25 | thirst | headache body ache chills very thirsty |
| 51 | 2021-01-25 | mouth tingling |
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t...
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warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
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| 51 | 2021-01-26 | taste impairment |
Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A ...
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Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A 51-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231, expiry date not reported), via an unspecified route of administration on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced chemical taste in mouth on 13Jan2021 14:00. The patient did not have COVID prior to vaccination and has not tested positive post vaccination. The patient was recovering from the event. No follow up attempts are possible. No further information is expected.
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| 51 | 2021-01-26 | eye itchiness, oropharyngeal discomfort |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-26 | taste impairment |
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t...
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metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 51 | 2021-01-26 | inability to speak |
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu...
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nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
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| 51 | 2021-01-27 | taste impairment |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-28 | mouth numbness |
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a...
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Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
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| 51 | 2021-01-28 | mouth numbness |
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi...
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Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
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| 51 | 2021-01-28 | dry throat |
Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reac...
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Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reaction associated with treatment of kidney stones. Allergist believed reaction was related to flomax or oxycodone (neither of these are injectable therapies. Vaccination given. Pt came to staff during the waiting period stating starting just minutes after the vaccination she started feeling of "dry throat." She also noted her heart beat was a little fast. No shortness of breath, no hives or any other signs of reaction. Pt was given diphenhydramine 25 mg orally at 1305. At 1325 Pt reports she is feeling better (she is conversing with friend and laughing). She states she will leave here and f/u with allergist regarding whether or not she should receive 2nd vaccination dose.
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| 51 | 2021-01-28 | mouth tingling, taste disorder |
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;...
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Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
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| 51 | 2021-01-31 | dry throat, mouth numbness |
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f...
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1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
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| 51 | 2021-01-31 | vision blurred |
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ...
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malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 51 | 2021-02-01 | eye irritation |
Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; D...
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Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; This is a spontaneous report from a contactable pharmacist reported a female patient. A 51-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via Intramuscular route of administration, on 18Jan2021 03:15 PM (at the age of 51 years old) as a single dose on left arm for COVID-19 immunisation at a workplace clinic. Relevant medical history included thyroid removed 30+ years (onset date unknown). Historical vaccine included fist dose of BNT162B2 (Pfizer Covid-19 vaccine, lot#/exp. date unknown) via Intramuscular route of administration on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021, the patient stated that day after receiving 2nd dose, she developed facial congestion, burning eyes, scratchy throat. She proceeded to get COVID Nasal Swab test on 19Jan2021 with unknown result at time of report. Patient stated workplace did not believe they were adverse reaction to vaccine. The patient received treatment no treatment. The outcome of the events facial congestion, burning eyes, scratchy throat was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 51 | 2021-02-01 | taste impairment |
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instruc...
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Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day
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| 51 | 2021-02-02 | gaze palsy |
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de...
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**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
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| 51 | 2021-02-02 | ear pain, pain in jaw |
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n...
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On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
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| 51 | 2021-02-02 | thirst |
Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, ex...
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Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, extreme thirst and fatigue. Tylenol taken temp continued to be 102 and increased to 102.4. All symptoms lasted until until 1/8/21 5am woke up sweating temp down to 99.8, arm pain, fatigue. 1/9/21 all symptoms resolved.
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| 51 | 2021-02-03 | mouth numbness |
After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had gen...
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After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had general fatigue the remainder of the day. The day following I was aching, bad headache and pain down my neck, my stomach was upset along with fatigue. These feelings came and went throughout Sunday 10, Monday 11, and Tuesday 12. I felt better on Wednesday Jan 13th. On Sunday January 23rd I started feeling very fatigued, achy and had a fever of 100 F. This lasted through Monday Jan 24
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| 51 | 2021-02-03 | mouth tingling, mouth numbness |
Numbness at left side of lip . Numbness almost like novicaine feeling at left cheek up towards lef...
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Numbness at left side of lip . Numbness almost like novicaine feeling at left cheek up towards left eye Tingling at back of the tongue
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| 51 | 2021-02-04 | vision blurred |
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o...
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Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
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| 51 | 2021-02-04 | swollen tongue, mouth swelling |
about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to sw...
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about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to swallow , constriction of throat. i was given an epi pen and taken to Emergency at Medical Center. I was released a couple hours later. I ended up going back to Emergency later on that evening but to Hospital. Tongue started to swell up again and was getting constriction of the throat and hard to swallow. Got released a couple hours later
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| 51 | 2021-02-05 | lip swelling, swelling of eyelid |
Lip swelling, eyelid swelling, are itching. Benadryl oral given. Sent to ER. 2nd day follow-up, n...
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Lip swelling, eyelid swelling, are itching. Benadryl oral given. Sent to ER. 2nd day follow-up, no further intervention was given in ER other than benadryl. At home and feeling "99%" better.
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| 51 | 2021-02-06 | loss of smell |
First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain n...
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First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain night of shot started a couple hours after. Had fever and chills start in the night, Thursday. I woke up to awful body and joint aches everywhere the next day, Friday. On Friday I also lost sense of smell. Had nausea, couldn't eat, fever, sweats awful and some chills off and on. Saturday- not much body aches but sweating awful, very tired/drained feeling. Sunday (today)- still sweats and nausea.
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| 51 | 2021-02-07 | lacrimation increased |
Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Mus...
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Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone. The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
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| 51 | 2021-02-07 | feeling of choking |
Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety...
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Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety). Monitored for 60 minutes and drank some water. Started to feel better. Patient said she experienced this after her first dose, but not until after she left the clinic. She said that time it resolved within 12 hours. Patient said she felt well enough to leave and said she'll seek medical help if symptoms don't resolve or worsen.
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| 51 | 2021-02-07 | ear itchiness, lip itchiness |
felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine ra...
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felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine rash in her bilateral forearm near the wrist; on and off pinpoint itch in different parts of her body; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via intramuscular route of administration on 22Jan2021 at 08:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included Chronic Hep B, borderline DM, HTN, high cholesterol. Concomitant medications included losartan, amlodipine, atorvastatin, metformin, fish oil, and docusate sodium (COLACE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 04Jan2021 at 08:30 am (age: 51 years), intramuscular, in the left arm for COVID-19 immunization; flu vaccine in 2010 and experienced allergies; and Penicillin G and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Jan2021 at 08:35, the patient felt warm. At the same time, her lower lip was slightly itchy. She also had pinpoint itch mostly in her scalp left ear and cluster fine rash in her bilateral forearm near the wrist, and four hours on and off pinpoint itch in different parts of her body. The patient was given Zyrtec as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-02-08 | swollen tongue, mouth numbness, ear discomfort |
1/27/2021 experience sore throat, chills, fever 101.8 F, and body aches. 1/28/2021 still experiencin...
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1/27/2021 experience sore throat, chills, fever 101.8 F, and body aches. 1/28/2021 still experiencing symptoms. Was sent to be test for Covid. Results were negative. 1/29/2021 Developed a dry nagging non-productive cough. I would have coughing fits that would last for 30-45 minutes, which would be followed by clear sinus drainage. I began taking Benadryl 50 mg q 4 hrs. with very little relief. 2/2/2021 I was seen at urgent care for this cough. CXR was negative. No signs of infection. I started prednisone 40 mg x 5 days, and Tessalon Perles 200 mg 3 times a day. I was still experiencing the dry cough and by 2/5/2021 had to leave work because the coughing was not letting up. I was now also experiencing my ears and throat itching. I again started taking Benadryl and sudafed q 4 hours. 2/7/2021 I tried to come off the benadryl and experienced ears itching, my throat itching, my lips were going numb and my tongue felt like it was swelling. 2/8/2021 I was seen by my primary care physician. There was no signs of infection. Ears were clear, chest was clear. He told me he felt I was having a reaction to the COVID vaccine, and experiencing a reactory cough as well. He gave me a Steroid injection in the office, prescribed me a steroid inhaler twice a day, and Bromfed cough syrup every 6 hrs prn. 2/9/2021 cough has subsided as well as the itching.
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| 51 | 2021-02-09 | ear discomfort |
Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report fr...
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Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report from a contactable other hcp reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 23Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included vertigo from an unknown date and unknown if ongoing, food intolerance to raw eggs, red dye and bag lettuce from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and paracetamol (TYLENOL). The patient previously had the first dose of the vaccine on 06Jan2021 (lot number: EK5730). On 24Jan2021 09:30 AM, the patient experienced vomiting about 17 hours after shot. Also, pressure in ears and like many others aches and chills. No treatment was received for the events. The outcome of the event was recovering.
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| 51 | 2021-02-10 | vision blurred, eye swelling, pain in jaw, toothache |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-11 | tunnel vision |
I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well. I went...
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I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well. I went to the ED for observation.
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| 51 | 2021-02-11 | sensitivity to light |
STARTED ON 2/11/2021 WITH HEADACHE ,FEVER ,CHILL,S BODYACHE, HEADACHE, LOSS OF APPETITE, NAUSEA, PAI...
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STARTED ON 2/11/2021 WITH HEADACHE ,FEVER ,CHILL,S BODYACHE, HEADACHE, LOSS OF APPETITE, NAUSEA, PAIN AND TIGHTNESS LEFT ARM AND LEFT AXILLA, LEFT CERVICAL PAIN, PHOTOPHOBIA. UNABLE TO GO TO WORK TODAY.
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| 51 | 2021-02-14 | eye disorder |
Acute inflammatory eye disease, vasculitis, iritis The first signs showed up the morning of 02/07/20...
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Acute inflammatory eye disease, vasculitis, iritis The first signs showed up the morning of 02/07/2021. I went to the eye doctor on 02/08/2021. Symptoms kept getting worse and I was referred to a retina specialist on 02/10/2021. I go back on Wednesday 02/17/2021. The retina doctor and family doctor have talked and they are recommending that I do not get the second dose at this time because I could be at risk of vision loss.
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| 51 | 2021-02-14 | tongue disorder, swollen tongue |
Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick. ...
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Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick. It made swallowing feel awkward but there was difficulty in breathing. When I got home, about 35-40 minutes after shot was administered I took some Benadryl. About 1 1/2 hours I felt back to normal.
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| 51 | 2021-02-14 | mouth tingling |
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left a...
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Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
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| 51 | 2021-02-14 | mouth swelling, eye swelling, swollen tongue |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
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| 51 | 2021-02-16 | mouth numbness |
Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and j...
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Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and jaw and left side of nose. Bad headache. At 5:53pm still feeling numbness on tongue and roof of mouth, but otherwise symptoms of subsided. Called doctor, Took 2 Benedryl (25 mg capsules).
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| 51 | 2021-02-18 | swollen tongue |
1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen admi...
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1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen administered. Patient alert 1256 - gagging, throat tightness, tongute better, tight throat, nausea; second Epi Pen administered 1258 - EMS arrived, pateint alert and transported to Emergency Department via EMS
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| 51 | 2021-02-18 | swollen tongue |
Vaccine administered at 10;25am; at 10:32, the individual began experiencing swelling of the throat ...
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Vaccine administered at 10;25am; at 10:32, the individual began experiencing swelling of the throat and tongue while seated in the observation area. Vital signs were checked and were withinnormal limits; she remained alert and oriented. A Code White was called; she had already taken Prednisone po from own supply since she has a history of an autoimmune disorder. The Code Team transported the individual to the ED via w/c for further observation.
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| 51 | 2021-02-21 | ear pain |
Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night wit...
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Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night with bleeding from right nostril and severe right ear pain
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| 51 | 2021-02-23 | swollen tongue, taste impairment, mouth numbness, mouth tingling |
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are...
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Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
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| 51 | 2021-02-24 | thirst |
Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea ...
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Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea that lasted for 10 days. That same day, I also developed extreme thirst, which persists today (22 days post-vaccine).
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| 51 | 2021-02-24 | mouth numbness, mouth tingling, lip swelling, swollen tongue |
Swelling of the lips and tongue, numbness and tingling of the mouth, sweating of the lips and mouth....
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Swelling of the lips and tongue, numbness and tingling of the mouth, sweating of the lips and mouth. Patient refused to be seen by EMS
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| 51 | 2021-02-25 | mouth numbness, mouth tingling |
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w...
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About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
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| 51 | 2021-02-25 | lip itchiness, mouth discomfort, mouth tingling, eye itchiness |
At the vaccine administration location, patient experienced the following symptoms: tightness in che...
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At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
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| 51 | 2021-02-26 | taste impairment |
About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I st...
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About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I stared to get a headache and tremors in my hands and arms. After another 5 min I was getting mussel tightness in my face and throte. I started to get dizzy and feel very cold.
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| 51 | 2021-02-27 | eye bleeding |
10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to ...
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10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to doctor and he also took blood pressures and still was in the 178-180 range. Never had high blood pressure in my life. Also experienced a broken blood vessel in my eye in between first shot and second shot.
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| 51 | 2021-02-27 | mouth tingling |
Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) ap...
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Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) approximately 12- 15 minutes after injection, dizziness, tingling mouth; ambulance called, taken to hospital, benadryl administered en route and steroids given at hospital
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| 51 | 2021-02-28 | ear pain |
Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, ...
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Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, low grade fever and earache right side only.
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| 51 | 2021-02-28 | ear discomfort, ear pain |
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headach...
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~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
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| 51 | 2021-03-01 | mouth tingling |
Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue ...
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Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue Treatment- benadryl; close monitoring for 2 hours by nurses and EMS workers
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| 51 | 2021-03-01 | thirst | Patient has been experience severe thirst since second vaccine administraiton |
| 51 | 2021-03-01 | lip swelling |
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our...
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Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
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| 51 | 2021-03-01 | mouth tingling | Tingling of my mouth and lips. Blisters in my gum and lips. |
| 51 | 2021-03-01 | vision blurred |
Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry...
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Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry. I checked my heat rate and it was 160. I motioned for the nurse and the pharmacist who was present monitored me for about an hour. My heart rate did not go below 110 for at least 45 min. I drank water and was allowed to leave once my HR was 88. I was able to drive home and did not have any other symptoms.
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| 51 | 2021-03-01 | swollen tongue, lip swelling | treatment - benadryl, hydration, rest, monitoring vitals at home |
| 51 | 2021-03-02 | taste impairment |
After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. Howev...
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After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. However, that went away within an hour. I had the typical low side effects of localized injection soreness, swelling, redness, warmth feeling and it was red around the injection site. The following two days after vaccination (2/22/21) I experienced the expected low side effects. On the third day after vaccination, I was feeling well again. However, yesterday 3/2/21, I noticed the area where I received the Covid vaccine was red again, with itching, warmth feeling, redness, and a bit of burning sensation. This is only apparent on the injection site. I contacted the CDC today, 3/3/21 and they directed me to you to report this and also to contact my healthcare provider, which I have. The CDC was not able to tell me if it was considered normal to have the localized injection site side effects resurface again a week after receiving the 1st dose vaccine. Therefore, I was advised by the CDC to report it. It is also unclear to me if the reason for the localized injection site side-effects being more prominent because of where the injection was administered. There is a question about it having been administered closer to subcutaneously by the nurse than intramuscular, but I do not know.
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| 51 | 2021-03-02 | swollen tongue |
Her tongue felt like it was swelling & she said it was getting difficult to swallow. Liquid Diphenh...
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Her tongue felt like it was swelling & she said it was getting difficult to swallow. Liquid Diphenhydramine 25 mg was given immediately. About 10 minutes later, another dose was given. About 5 minutes after the 2nd dose of Diphenhydramine was given, she stated her tongue was getting worse & she was having a more difficult time swallowing. Epi 0.3 mg given IM. Within about 3-4 minutes, she stated she was feeling better. Then, about 5 minutes later, she stated her tongue was beginning to swell again. She was immediately taken to the ED for treatment. Steroids were given. Pt was discharged from the hospital. She is feeling much better today (the day after the event).
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| 51 | 2021-03-02 | ear itchiness |
Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved ...
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Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved after a short time. I still have periodic itchiness of face and neck. I take claritin everyday.
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| 51 | 2021-03-02 | ear pain |
Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever c...
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Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever chills. Severe internal ear pain and headache but it's not touched by Tylenol or Ibuprofen
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| 51 | 2021-03-02 | thirst |
Patient is a volunteer at a vaccine distribution center. She was able to get a vaccine herself beca...
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Patient is a volunteer at a vaccine distribution center. She was able to get a vaccine herself because of this. She reports a persistent vice-like headache that began the day she received her first dose of vaccine that has persisted. Her blood pressure went up with this, so she was started on metoprolol which brought her blood pressure down, but did not affect the headaches. Patient received her 2nd dose of the Pfizer vaccine on 2/27/21 and reports that in addition to the headache she feels fatigued and reports excessive thirst. She is still be worked up for the headaches.
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| 51 | 2021-03-03 | ear pain, mouth discomfort, tongue discomfort |
20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose ...
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20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose red rash at injection site, extreme fatigue and symptoms previously stated. 72 hours after dose extreme fatigue, swelling and discoloration at injection site with unusual feeling in right arm, mouth, tongue and lip burning. 96 hours after injection until present, extreme fatigue, burning mouth, tongue and lip sensation, unusual feeling in right arm.
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| 51 | 2021-03-03 | mouth numbness | Feeling of weakness, numbness around fingers and mouth, nausea. |
| 51 | 2021-03-03 | vision blurred, sensitivity to light |
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz...
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Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
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| 51 | 2021-03-03 | ringing in ears |
One week and approx. 7 hours after injection, an existing mild tinnitus in the right ear became noti...
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One week and approx. 7 hours after injection, an existing mild tinnitus in the right ear became noticeably worse. Three days after that, a bilateral higher frequency buzzing tinnitus (that presents over the head rather than in the ear) appeared. Prior existing tinnitus levels were previously unnoticeable throughout the day (able to successfully ignore and forget about) but now both are noticeable throughout the day and take quite a bit of effort to distract myself from.
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| 51 | 2021-03-03 | deafness, ringing in ears |
Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg ...
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Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.
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| 51 | 2021-03-03 | mouth itchiness |
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),...
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half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
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| 51 | 2021-03-06 | taste impairment |
At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Ju...
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At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Just felt weird like a heaviness all over my body. About 3:10 I started getting a metal taste in my mouth and throat it was gone by 3:30, but kept coming back through the rest of the day and next morning. By evening 8:45 PM my arm where shot was given started to hurt and bothered me through the night could not lay on it. Next morning my arm was hurting really bad at injection site and was warm to touch. I had some errands to do so I did use the arm sometimes the pain was not as bad other times just my coat touching my arm hurt. Around 4pm I took a tylenol and slept a little not better. Sunday morning March 7 it was still sore not as bad, but after using while doing some chores it is now burning and hurting again at 2pm. I feel nauseous and really dont have a appetite.
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| 51 | 2021-03-07 | eye itchiness |
15 minutes after receiving vaccine, client stated she had symptoms of "hayfever." Eyes itchy, nasal ...
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15 minutes after receiving vaccine, client stated she had symptoms of "hayfever." Eyes itchy, nasal congestion, runny nose, headache, sore throat. Denies feeling of throat closing or SOB. Long history of allergies-esp tree nuts . Brought by wheelchair to med exam area: A&O x 3, BP 138/70, Chest: CTA, Cardio: RRR 85 bpm, eyes erythematous, RR 15. Given cold water and kept in med station for an hour. Declined transfer to local ED for further eval/tx. Stated she was improving, symptoms much better. Eyes appeared clear w/out erythema, eupneic, no SOB. States feeling much better. Client stated she was well enough to go home and asked to leave. She then left for home.
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| 51 | 2021-03-07 | ear discomfort |
Fever from 99.7 as high as 101.1 for 36 hours s/p vaccine - Treated with acetaminophen and ibuprofen...
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Fever from 99.7 as high as 101.1 for 36 hours s/p vaccine - Treated with acetaminophen and ibuprofen Clogged ears. - treated with Mucinex
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| 51 | 2021-03-08 | inability to speak, mouth tingling |
Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches...
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Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches, slight tingling on the tongue, and eventual loss of voice over the subsequent two days. The on duty nurse who had administered the shot, strongly suggest that I drink lots of water and take Tylenol. March 6 and 7, my voice was to a whisper; however, the body aches and tingling of the tongue had subsided. I was extremely exhausted and unable to speak above a whisper on March 8, but did not experience any of the aforementioned side affects. Today, March 9, my voice is back above a whisper, with intermittent hoarseness. I will continue regiments of rest, Tylenol, hot tea with crushed ginger. It is important to note that my breathing had not been affected since having taken the 2nd shot on March 5, 2021.
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| 51 | 2021-03-08 | mouth numbness, mouth tingling |
Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/...
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Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 51 | 2021-03-08 | mouth tingling, mouth numbness | flushing, lip numbness/tingling, lightheaded, HA. Evaluated by EMS-Cleared |
| 51 | 2021-03-09 | dry mouth |
One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I ...
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One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
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| 51 | 2021-03-09 | loss of taste, swollen tongue |
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with...
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Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
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| 51 | 2021-03-10 | oropharyngeal discomfort |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT STATE...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT STATED FEELING UNCOMFORTABLE IN THE THROAT AFTER HER 15 MINUTE WAITING PERIOD WAS UP. PATIENT STATED THAT IT WAS MORE OF AN ITCH THAN SWELLING/TIGHTENING OF THROAT. PATIENT REQUESTED BENADRYL TO BE ADMINISTERED. 1 TAB OF 25 MG BENADRYL WAS ADMINISTERED. PATIENT BLOOD PRESSURE WAS ALSO MONITORED. PATIENT WAS KEPT FOR AN ADDITIONAL 30 MINUTES BEFORE LEAVING. FOLLOW UP CALL WAS GIVEN TO PATIENT APPROXIMATELY 40 MINUTES LATER AND PATIENT STATED SHE FELT FINE.
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| 51 | 2021-03-10 | mouth tingling, mouth numbness | tongue numb/tingling, "medicine head", HA. Evaluated by EMS-Cleared |
| 51 | 2021-03-12 | mouth numbness, taste impairment |
Patient complained of headache, metallic taste and numbness on the sides of tongue. She was given 50...
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Patient complained of headache, metallic taste and numbness on the sides of tongue. She was given 50mg oral benadryl at 11:55am. No further intervention required. Discharged to home.
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| 51 | 2021-03-12 | mouth tingling |
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ...
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Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
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| 51 | 2021-03-13 | taste disorder |
WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOU...
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WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOURS AFTERE SHOT) PAIN/SORENESS AT INJECTION SITE AND IN UPPER ARM, DIGESTIVE DISCOMFORT
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| 51 | 2021-03-14 | lip swelling |
10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips...
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10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips began to feel swollen, chills. Took a Zyrtec and symptoms went away within an hour.
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| 51 | 2021-03-14 | ear discomfort, ear pain |
Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 ...
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Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
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| 51 | 2021-03-14 | vision blurred |
HARD TO FOCUS VISION, IMPROVING AFTER 5-10 MINS, CHECKED I WITH PARAMEDICS . LEFT BY HERSELF AFTER ...
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HARD TO FOCUS VISION, IMPROVING AFTER 5-10 MINS, CHECKED I WITH PARAMEDICS . LEFT BY HERSELF AFTER RECOVERING.
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| 51 | 2021-03-14 | loss of smell |
Healthcare worker tested positive by PCR for Covid-19, >14 days post second covid vaccination. Her...
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Healthcare worker tested positive by PCR for Covid-19, >14 days post second covid vaccination. Her husband was positive for covid last week. Her symptoms are cough, headache, congestion and loss of smell.
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| 51 | 2021-03-14 | ringing in ears |
I had tinnitus after the first dose on 2/20/2021 the same day under Lot #EL9267. It had reduced in i...
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I had tinnitus after the first dose on 2/20/2021 the same day under Lot #EL9267. It had reduced in intensity over the 3 weeks. Yesterday, after the 2nd dose, the tinnitus got stronger by the late afternoon again. There is no treatment.
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| 51 | 2021-03-14 | hearing loss, ringing in ears, ear discomfort |
Within 24 hours ears felt stopped up but some sounds were roaring. Difficulty hearing others talk. ...
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Within 24 hours ears felt stopped up but some sounds were roaring. Difficulty hearing others talk. Still having problems but it is improving slowly. This happened after 1st vaccine and lasted for about a week. I just didn?t link it to the vaccine until the experience returned after the second dose.
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| 51 | 2021-03-15 | dry mouth |
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5...
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Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
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| 51 | 2021-03-15 | mouth tingling |
TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HAL...
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TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HALF AFTER SHOT DRANK WATER IT LASTED 15 TO 20 MINUTES. SOME DAYS STILL ITCHY AND TIRES ALSO EXTREME FATIGUE
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| 51 | 2021-03-16 | swollen tongue, mouth swelling, double vision, lip swelling |
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi...
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1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
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| 51 | 2021-03-16 | ringing in ears |
4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. ...
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4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. Ibuprofen and Benadryl 50mg taken. Symptoms resolved. 5 days later, tinnitus in right ear occurs and has been ongoing since then.
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| 51 | 2021-03-16 | ringing in ears |
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6...
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Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
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| 51 | 2021-03-17 | lip swelling |
Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that aft...
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Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that afternoon, she had generalized hives, malaise, and started wheezing. She developed additional symptoms of lip swelling, edema, lightheaded, dyspnea. She had medical contacts with telemedicine, 2 office visits here with her PCP and a couple phone follow ups with her PCP. She was treated with benadryl, a 10 day prednisone course and a ventolin inhaler. Her symptoms resolved after a week.
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| 51 | 2021-03-18 | mouth swelling, swollen tongue |
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 mi...
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Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
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| 51 | 2021-03-18 | ringing in ears, deafness | Immediate pain right side of neck and hearing loss than ringing in both ears |
| 51 | 2021-03-18 | mouth numbness, tunnel vision |
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva...
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Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
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| 51 | 2021-03-19 | taste impairment |
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ...
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Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
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| 51 | 2021-03-19 | eye pain |
Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus inf...
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Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus infection. I became shaky and tingly. My arm was sore and felt heavy. My face became dark red and was hot to the touch. All symptoms still continue now (27 hours later) however my face is not as dark red, just pink. About 10 hours after the vaccine my muscles in my neck and shoulders began to ache. I was very fatigued. My entire body felt week and movement become a chore. Worst symptoms: Through the night I began to experience acid reflux. I have only experienced this a couple of times in my life and very mild. This was severe to the point that I couldn't sleep, my throat burned from the acid. Even drinking water was very painful and it would come back up. I located some Tums and ate 4. This was also a challenge as I couldn't hardly swallow due to the pain. After about 35 min. I began burping which help a little with the ability to keep some water down. Today I feel exhausted, my eyes still hurt, still have the headache and sinus pressure, and continue to have the acid reflux but not as severe as the night and early morning. I haven't tried to eat yet today.
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| 51 | 2021-03-20 | taste disorder, ringing in ears |
Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficul...
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Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficulty swallowing. Disorientation. Close to passing out. About 3 hours after vaccine I was intensely nauseous.
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| 51 | 2021-03-20 | ringing in ears | constant ringing in ears |
| 51 | 2021-03-21 | swollen tongue |
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ ap...
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Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation. She was taken to Regional per EMT's.
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| 51 | 2021-03-22 | taste disorder |
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo...
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Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
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| 51 | 2021-03-22 | taste impairment | No treatment needed. Patient stated she has a metal taste in her mouth. 1310. |
| 51 | 2021-03-22 | lip swelling, mouth tingling, swollen tongue, mouth numbness |
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ...
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Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
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| 51 | 2021-03-22 | lip swelling | throat scratchy and lips swelled at 2 hours after shot |
| 51 | 2021-03-23 | tongue disorder, dry mouth, thirst |
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger ...
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I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
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| 51 | 2021-03-23 | taste impairment |
Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours...
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Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours rest of face.
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| 51 | 2021-03-24 | swollen tongue |
Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vom...
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Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vomited. Patient was observed for s/sx of anaphylaxis. Patient was given 25mg diphenhydramine, temperature checked (temp had elevated ~2 degrees from time of injection), pulse and breathing function. Pt was visibly flushed in the face. Patient was given a cool rag as well. Patient was A&Ox3. Pt did not report any immediate issues of breathing issues, cardiac abnormalities, etc. Injection site was unremarkable. Pt reported feeling a bit better after the medication. About 7 minutes later, patient began to complain of scratchy throat and minor difficulty breathing. Patient does have a history of atopic reactions and has noted this sensation in the past when experiencing allergic reactions. Observed patient tongue and mild signs of angioedema were noted. Patient given second dose of diphenhydramine and water. Epipen was on site. Patient was observed and monitored for 25 minutes further. After approx. 5 more minutes, patient reported feeling better and looked visibly less flushed and the swelling of the tongue had diminished. Approx 5-10 min later patient was walking around, talking normally, and showed no signs of distress or reaction.
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| 51 | 2021-03-24 | mouth tingling |
Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use res...
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Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use rescue inhaler 2X; Tingling sensation of tongue w/i 10 min of injection; Lips felt puffy w/i 10 min of injection; Increased heartbeat - RN measured it at 95 BPM after injection w/i 10 min of injection - normally it is at 66 BPM resting; Bad rash on left arm around injection site after returned home 1 hour later - took orally one Benadryl tablet 25mg Dizziness w/i 15 min of injection - had to lay down at hospital; Felt sick to stomach w/i 15 min of injection - had to lay down at hospital
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| 51 | 2021-03-24 | oropharyngeal discomfort, mouth tingling | Tingling tongue, fullness in back of throat, difficulty swallowing, rapid heart rate |
| 51 | 2021-03-25 | taste impairment |
As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a ...
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As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a minute as well
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| 51 | 2021-03-25 | oropharyngeal discomfort |
At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately ...
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At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately 30 minutes post-vaccination due to previous reaction to flu vaccine. Vital signs were taken by MSN RN and EMT at 1405 with BP of 179/98, HR 72 and O2 Sat of 95%. Patient also stated that "her throat felt like something was stuck in it like indigestion". Patient also states that she took 1000 mg of Tylenol at 1200 with food prior to vaccination. At approximately 1430, a second set of vital signs were taken with BP 179/89, HR 73, and O2 sat of 95%. Patient was offered and accepted ambulance for further evaluation. Due to increased BP and HA, patient was then transported to Regional Hospital for further evaluation.
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| 51 | 2021-03-25 | mouth itchiness |
I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back ...
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I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had a significant headache. I could not sit up straight due to dizziness. By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow. I was too dizzy to stand up. I would tip over when I stood up. The hospital was called and advised my family to closely observe my symptoms. At 11:20 the pharmacist gave me liquid Benadryl. At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol. At 12:30 my throat felt less enflamed but sore and scratchy. At this time my whole head was itchy and the headache was not reduced. I had a difficult time walking due to the dizziness.
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| 51 | 2021-03-25 | mouth tingling, mouth numbness | Pt experienced immediate numbness and tingling in her mouth, No LOC or local site reaction notes. |
| 51 | 2021-03-25 | taste disorder |
body aches, taste of the medicine in my mouth, felt the shot move through my chest and tired from sh...
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body aches, taste of the medicine in my mouth, felt the shot move through my chest and tired from shot for over 5days
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| 51 | 2021-03-25 | mouth numbness, mouth tingling, lip swelling |
tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from sh...
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tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from shoulders down to fingertips that happened simultaneously (one occurence), slight swelling and tingling sensation of lips.
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| 51 | 2021-03-26 | ringing in ears | High pitch - medium intensity constant ringing on both ears |
| 51 | 2021-03-28 | inability to speak |
autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fati...
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autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EN6199) injected intramuscularly in left shoulder (left arm) on 09Mar2021 13:30 at age of 51 years old at single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Ehlers-Danlos syndrome (EDS), neurosarcoidosis (diagnosied 1997 with remission since 2002), high cholesterol, depression, gastrooesophageal reflux disease (GERD), osteoarthritis. Allergies to penicillin (no specific manufacturer, lot or expiration) in 1990. Obesity through all her life. No relevant test. Diagnosed allergies, compromised immune status, respiratory illness. There was no family medical history. Patient was not pregnant. There were no additional vaccines administered on same date of the Pfizer Suspect. There were other medications in two weeks. There was not covid prior vaccination. There was no other vaccine in four weeks prior vaccinations. The adverse event patient experienced: lose of voice with shortness of breath with communication and chest tightening, fatigue. This similar to her neurosarcoidosis diagnosied 1997 with remission since 2002. The events started on 10Mar2021 11:30 AM. Received call from consumer regarding the Pfizer COVID vaccine 1st dose. She was losing her voice. She was a pediatric Occupational Therapist. She was eligible on Tuesday for the first dose and went and got it. Her main concern was the symptoms she was having was the same thing that comes out when her autoimmune was exacerbated. She would like to know if it was safe to get next dose. When providing her weight, she said she was not a small girl. There was no prescriber. She was waiting to see if it would disappear before calling Pfizer to report it and it did not. It started yesterday about 24 hours after the vaccine. She received it for prevention and for the population she works with. A lot of her kids she worked with were autoimmune compromised. The majority of her medications she had been on for over two years, so she did not feel they were relevant. No further details provided. No Emergency Room (ER) or physician's office required. She called her physicians' office and they suggested she contact Pfizer. Patient received covid tested post vaccination: nasal Swab/Antigen on 09Feb2021: negative. Outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-03-28 | ringing in ears, hearing loss, deafness unilateral |
lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hea...
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lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hearing like a buzzing sound, hollow sound; she couldn't hear very well; This is a spontaneous report from a contactable consumer. This consumer reported for a 51-year-old female patient (Reporter's sister-in-law) that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247;solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient's age was 52 years old at the time of vaccination with weight 76.644 kg, height; 154.94 cm. Patient's medical history included diabetes. Patient's concomitant medications included Metformin at 1000 mg for diabetes, Lisinopril at 10 mg for blood pressure, Insulin at 100 units, Atorvastatin at 40 mg (therapy dates unspecified). Reporter stated, "This is regarding my sister-in-law, it's in regards to, I had called few weeks ago and they had told me to call back I need to know who do I speak to as I need to send some paper work. She had a reaction to the Covid injection and I have all the paper work here. They told me that we needed to send also that they are going to try and see how she can get compensated back because she had to go to the hospital, she had to go to the urgent care twice, she had to see specialist and things like that." Reporter stated, "On 29Jan2021 (Later corrected), she got it done at work and couple of hours later she started hearing like a buzzing sound, she end up she couldn't hear very well and then the next day she (word incomprehensible) out of her right ear. It's been like the longest time. Pfizer EL3247." Treatment: Reporter stated, "Well she went to the urgent care twice although she had, one doctor said she had sinus infection the other doctor said she had ear infection. So, she went to a specialist ENT and he said she had none of those infections. He did put her on Prednisone because she lost hearing of the right ear so, he gave her 10 mg of Prednisone, gave 6 tablets 5, 4, 3 like that." She did not take the 2nd vaccine. She had loss of hearing, a buzzing sound, hollow sound, still has loss of hearing in right ear. Reporter was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 am to 8 pm Monday to Sunday as per (EST). Investigation assessment; no. The outcome of events was not recovered for lost hearing of the right ear and for other events were unknown.
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| 51 | 2021-03-30 | ear pain, oropharyngeal discomfort |
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with...
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Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 51 | 2021-03-31 | eye disorder, hearing loss, eye irritation |
hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and g...
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hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.
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| 51 | 2021-04-12 | visual impairment |
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ...
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Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
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| 51 | 2021-04-12 | eye strain |
I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My bod...
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I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My body is itchy and feel like crap; My body is itchy and feel like crap; she's allergic to the Covid 19 vaccine; I was wheezing within 10 minutes after receiving the first dose of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8732 and expiry date: 31Jul2021) via an unspecified route of administration in left arm on 29Mar2021 at single dose for covid-19 immunisation. Medical history included Multiple sclerosis (from 1996 to ongoing), 2006-2007, it was because of an MS drug (Interferon (receiving 3 times a week)), it gave her mild cardiomyopathy. She just stopped taking another treatment for multiple sclerosis called Mavenclad. Mavenclad is a chemotherapy drug. She received her first dose in Oct2020, she took Mavenclad for 5 days. Then in Nov2020 she started taking the Mavenclad again for 5 days. She doesn't restart the Mavenclad again until Oct2021. She reports the Mavenclad takes the B and T cells out of her bone marrow. When she has the next dose of Mavenclad, the B and T cells will be depleted again and when the B and T cells come back they are "tricked" so they won't attack her body. Her hair fell out in clumps with the Mavenclad and her throat swelled too. She would really like a haircut to fix her hair. She premedicated prior to receiving the Mavenclad. She reports she was premedicated for 3 days prior and the day she received the Mavenclad, with Benadryl. Within 15 to 20 minutes of taking the Mavenclad she had a reaction. Concomitant medications included vitamin b12 (about a year) for vitamin b12 deficiency and vitamin d (10-15 years) with calcium for Vitamin D deficiency. On 29Mar2021 within 10 minutes after receiving first dose her throat swelled up. The next thing she knows is people are all around her, she's on a gurney and she's going to the hospital in an ambulance. She would say she's allergic to the Covid 19 vaccine. In the emergency department she had to have an IV with all kinds of medications. Yesterday in the emergency department the doctor wanted to give her an epi pen. She told the doctor she didn't want to have the epi pen. In her IV in the emergency department she received Solu-Medrol, Benadryl (as needed), and Famotidine (20mg twice a day 10 days). She was prescribed Prednisone 20mg tablets, take 3 tablets orally every day for 5 days. She also reports she is allergic to egg whites, not deathly allergic. She can eat a hardboiled egg but she has to take Benadryl because her throat will start to close up. She can eat scrambled eggs just fine because the eggs are cooked different. The emergency room was watching her because if she didn't improve, they were going to give her the epinephrine. She started to improve, and she was thankful. She was afraid something else could have happened to her and her husband was in the parking lot and wouldn't have known. She's not sure how many hours she spent in the emergency room. She was not admitted to the hospital; she was discharged from the emergency room. Now she's taking medication for the next 5-10 days. She's not shocked, with her history and her reactions to medications. She didn't really think an allergic reaction was going to happen because the Covid 19 vaccine is not a live vaccine or anything like that. She's not going to look online for allergic reaction information because her eyes are tired. She's been up since 1:30 AM because of all the steroids she's on. On 30Mar2021, her whole body is itchy. She's taking Benadryl and the Benadryl has helped. The itchy feeling is moving on to different parts of her body. She had the swine flu when it came out and it was hellacious. She feels like Covid is much worse and she she believes in science. She knows Covid 19 isn't made up. She's all for the Covid 19 vaccine. Give her the Covid 19 vaccine so she can move on. She reports everyone in her family got the vaccine, and they were all fine besides aches and pains. When probing for specific information regarding the caller's family members, she reports her daughter, who is in nursing school had the Covid 19 vaccine. After her daughter's first Covid 19 vaccine, she had a sore arm that night and she was really tired. The next day her daughter felt a little lightheaded and she felt like she had flu symptoms. She had some body aches. Then under her daughter's armpit where her lymph nodes are were swollen. By the third day her daughter felt better. She was totally fine. She thinks her daughter may have reported her experience online. The outcome of event eyes are tired and I was wheezing within 10 minutes after receiving the first dose of the vaccine was unknown, the outcome of event My body is itchy and feel like crap, My body is itchy and feel like crap and she's allergic to the Covid 19 vaccine was not recovered where the patient recovering from the event I was brought to the hospital by the ambulance because my throat swelled up.
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| 51 | 2021-04-15 | eye twitching, swelling of eyelid, double vision, pain in jaw, vision blurred |
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin...
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Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
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| 51 | 2021-04-20 | loss of taste, swollen tongue |
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; c...
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Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. More information has been requested.
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| 51 | 2021-04-24 | vision blurred, visual impairment, ringing in ears |
My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so ...
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My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
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| 51 | 2021-05-04 | ear swelling, ear itchiness |
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa...
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Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
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| 51 | 2021-05-10 | taste impairment |
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches...
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Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient). The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization. Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration. After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
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| 51 | 2021-05-11 | deafness |
Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a cont...
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Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0162 and expiry date: Jul2021), via an unspecified route of administration, in Arm Left, on 08Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included thyroid problem and seasonal allergies. The patient did not have any family medical history relevant to events. The patient did not receive any vaccine within 4 weeks prior to vaccination. Concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID- 19 vaccine on 08Apr2021 and one day later on 10Apr2021 when she woke up in the morning, she lost hearing on her right ear. She mentioned her doctor told her she should call. She called her physician, and she did not have any accident or anything outside, she was healthy, she only had the vaccine. It bothers her. She described noise in her ear like a dog barking and her ear feels like a big pressure and every time she heard crying or talking or a loud sound, she could not hear. Her doctor never heard of this with the vaccine. She went to see a primary doctor and her HCP said this was due to allergies and pollen, because it was April and he said that he never heard of a hearing loss for COVID vaccine and prescribed Meclizine. She did not have allergy problems and anything wrong with her sinus or a runny nose, so she decided to go to a professional doctor, ear nose and throat. Then she went to see a ear nose and throat doctor on 15Apr2021 and 21Apr2021, and he said that he heard about a couple of cases with the vaccine and he tested her by performing a hearing test and it was true that the COVID-19 vaccine caused nerve damage. She was deaf in her right ear, her test came back horrible, she could not hear. The patient (withheld) said that this was because of the COVID virus in the vaccine, that destroyed nerves in the right ear and that was why she could not hear. She was currently taking Prednisone 10mg tablets, take 6 tablets for 3 days, and then 5 tablets for 3 days, and then 4 tablets and changes every 3 days. The patient was prescribed with meclizine 25mg tablets to take 3 times a day for dizziness. She did not have the dizziness when she took the pills. The patient also reported that she was healthy before and she usually takes the flu shot every year and this never had happened before. She was COVID-19 positive on 06Feb2021. She had COVID on 14Feb2021. The events did not require a visit to emergency room. The events were resulted in physician office visit. She would like to verify if this has happened to someone else before and if her hearing will return. The COVID-19 vaccine destroyed her health, and second vaccine was scheduled for 03May2021. The patient would like to know if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first dose. The patient got response that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The patient was referred to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knows your health situation and has access to information that can better help inform this decision. Follow up attempts are possible further information is expected
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| 52 | 2020-12-31 | ringing in ears | Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h. |
| 52 | 2021-01-01 | eye irritation, dry eye |
After receiving the vaccine, my eyes got severely dry to the point I had to use drops. They felt li...
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After receiving the vaccine, my eyes got severely dry to the point I had to use drops. They felt like sand was blown in them.
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| 52 | 2021-01-02 | oropharyngeal discomfort |
About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. ...
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About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. Difficulty breathing
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| 52 | 2021-01-02 | mouth tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-03 | mouth numbness |
52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial dr...
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52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
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| 52 | 2021-01-03 | taste impairment |
Immediately I had a bitter/metal taste at the end of my throat. It last about 5 hours and and ended...
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Immediately I had a bitter/metal taste at the end of my throat. It last about 5 hours and and ended about 2:30-3:30pm. I had a bitter/metal taste when I ate anything or drank water.
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| 52 | 2021-01-03 | mouth tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
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| 52 | 2021-01-04 | thirst |
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe...
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Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| 52 | 2021-01-04 | feeling of choking |
Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient ...
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Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received first dose of BNT162B2 (lot number: EH9899; expiry date: 31Mar2021), via an unspecified route of administration, on 28Dec2020 10:00 am (left arm), at a single dose, for COVID-19 vaccination. Relevant medical history included hypertension and seasonal allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took losartan, sulfa, ultram, morphine, codiene, and lisinopril and experienced allergies. On 28Dec2020, at 10:15 a.m., the patient experienced tingling in throat and throat swelling. The patient received Benadryl as treatment for the events. Outcome of the events was recovering.
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| 52 | 2021-01-04 | ringing in ears | Woke up at 3:30 am due to ringing in my left ear. Ringing has continued all day. |
| 52 | 2021-01-05 | swollen tongue |
10 minutes after administration, back of tongue and soft palate started feeling strange sensation wi...
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10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 52 | 2021-01-05 | loss of taste |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | loss of smell, loss of taste |
High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR...
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High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR ABOUT A WEEK; tested positive for COVID on Dec 26. haven't recovered inablity to smell or taste; fatigue - still have that, too;
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| 52 | 2021-01-05 | taste disorder |
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t...
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the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-06 | bloodshot eyes, eye swelling, eye itchiness |
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon re...
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Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.
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| 52 | 2021-01-06 | eye twitching, mouth tingling, mouth numbness |
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t...
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Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
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| 52 | 2021-01-06 | mouth numbness | Diarrhea numbness of face/tongue Narrative: |
| 52 | 2021-01-06 | vision blurred |
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B...
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Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
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| 52 | 2021-01-06 | ringing in ears |
constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level an...
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constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level and then increases to higher and louder. no dizziness, lightheadedness, nausea, visual disturbances, numbness or tingling - it is just the ringing.
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| 52 | 2021-01-07 | eye swelling |
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i...
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12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
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| 52 | 2021-01-07 | mouth tingling, feeling of choking |
5 minutes after injection had internal thickening of throat and difficulty swallowing. After a coupl...
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5 minutes after injection had internal thickening of throat and difficulty swallowing. After a couple of minutes swallowing improved but throat thickening continued for another approximately 15 minutes. At 50 minutes after the injection had faint tingling around the mouth and mild throat internal throat thickening again. Took 25 mg of Benadryl. No further s/s.
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| 52 | 2021-01-07 | taste impairment |
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout...
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After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
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| 52 | 2021-01-08 | tongue itchiness, ringing in ears, swollen tongue |
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h...
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Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
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| 52 | 2021-01-09 | swollen tongue | Turned red in upper torso, swelling to tongue and heightened blood pressure. |
| 52 | 2021-01-10 | swelling around the eyes |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | mouth tingling, mouth numbness |
Employee experienced numbness and tingling of lips and mouth which occurred approximately twenty (20...
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Employee experienced numbness and tingling of lips and mouth which occurred approximately twenty (20) minutes after receiving second dose of Pfizer COVID-19 vaccine. Employee was taken to the Emergency Department for treatment. Employee received two (2) doses of Decadron 6 mg by mouth, Benadryl 50 mg by mouth, and Pepcid 40 mg by mouth.
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| 52 | 2021-01-10 | ear pain |
Left arm pit pain, left neck pain, intermittent left ear pain. Tolerable mild discomfort. No treat...
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Left arm pit pain, left neck pain, intermittent left ear pain. Tolerable mild discomfort. No treatment.
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| 52 | 2021-01-10 | sensitivity to light |
Migraine headache began the next morning about 7am and increased as the day progressed including nau...
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Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
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| 52 | 2021-01-10 | ringing in ears | Muscle ache and tinnitus. Denies hearing loss |
| 52 | 2021-01-10 | swelling of eyelid, eye pain |
within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-fill...
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within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021
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| 52 | 2021-01-11 | eye swelling, eye itchiness, lacrimation increased |
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye...
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Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
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| 52 | 2021-01-11 | mouth numbness |
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir...
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Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
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| 52 | 2021-01-11 | mouth numbness |
Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving ...
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Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving home. Took 1 benadryl when I got home and all symptoms subsided approx 30 minutes later.
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| 52 | 2021-01-11 | mouth numbness |
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ...
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injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
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| 52 | 2021-01-12 | mouth numbness |
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use...
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At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
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| 52 | 2021-01-12 | deafness, ear discomfort, ringing in ears |
I had a mild headache the evening of the shot, I had a headache the next two days that was relieved ...
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I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.
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| 52 | 2021-01-13 | mouth tingling, ear discomfort |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-14 | swollen tongue, mouth tingling |
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ...
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1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
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| 52 | 2021-01-14 | vision blurred |
Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision re...
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Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision resolved, no improvement in generalized body aches.
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| 52 | 2021-01-14 | loss of smell, loss of taste |
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b...
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Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
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| 52 | 2021-01-14 | ear pain, pain in jaw |
Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination....
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Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination. Still experiencing as of 1/15/2021. On 1/14/2021 experienced throbbing under ear to jaw bone.
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| 52 | 2021-01-14 | mouth discomfort, mouth tingling | Sores on inside of lips, burning tingling lips |
| 52 | 2021-01-14 | ear pain |
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a...
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neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
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| 52 | 2021-01-16 | mouth numbness, mouth tingling |
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. Th...
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I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen. No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken. Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
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| 52 | 2021-01-16 | burning mouth syndrome |
The next morning after I received the vaccine I had multiple kanker sores on my tongue. Around 6 of ...
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The next morning after I received the vaccine I had multiple kanker sores on my tongue. Around 6 of them. Seven days later they are no better or worse. I am not sure if it related to the vaccine or not but I have rarely ever had a kanker sore and in the past, if I did it would only be one and would be gone in a few days. This was my second vaccine of the series of the Pfizer-BioNTech COVID-19 Vaccine EUA. My first one was on 12/28/2020. I did not have any sores after the first vaccine.
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| 52 | 2021-01-17 | mouth tingling, tongue disorder |
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben...
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Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
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| 52 | 2021-01-17 | mouth tingling | Sore arm Tingling lips |
| 52 | 2021-01-18 | deafness |
After 3 days 1st dose loose hearing then went to ER. They told me ears was clear no fluid given ster...
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After 3 days 1st dose loose hearing then went to ER. They told me ears was clear no fluid given steroids' to take. I went Hearing specialist was told by doctor I have 80% right hearing loss.
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| 52 | 2021-01-18 | pain in jaw |
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side...
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Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
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| 52 | 2021-01-19 | tunnel vision |
Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to...
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Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to pick head up off pillow for 2 days. Unable to eat or drink as well.
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| 52 | 2021-01-20 | oropharyngeal discomfort |
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 1...
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10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided. 50 min. after vaccine injection: flushed, redness in face, ears, and neck progressing to rash on chest, neck. Lasted for about 10min and subsided. Never progressing into full anaphylaxis reaction. No treatment taken.
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| 52 | 2021-01-20 | dry mouth, thirst |
I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then seve...
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I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then severe dry mouth and cold on Sunday and Monday. I just made sure to stay hydrated. On Tuesday I felt better but when I got up on Wednesday morning, I felt dizzy. It progressed into the day and became worse. I had to go home from work and was unable to drive. Today, I feel slightly better but still dizzy if I get up quickly.
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| 52 | 2021-01-20 | swelling of eyelid |
Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyeli...
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Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyelids.
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| 52 | 2021-01-21 | visual impairment |
Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took ...
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Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took benadryl. When I woke up the next morning I was extremely dizzy and fell in the shower. It was more than just being dizzy it was like I couldn't see and it was hard to pick myself up. I may have fainted because I didn't recall falling just noticed I was on the shower floor. I thought I had gotten up but then again I was still on the floor. I made it back to bed and slept for a few hours. After that I seemed fine.
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| 52 | 2021-01-21 | mouth discomfort, ear discomfort |
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ...
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immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
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| 52 | 2021-01-22 | ringing in ears, mouth tingling |
Approximately 45 mins after vaccine, 1620 - NP 169/74, HR 71 - c/o scratchy throat and lightheaded a...
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Approximately 45 mins after vaccine, 1620 - NP 169/74, HR 71 - c/o scratchy throat and lightheaded and ringing in ears. 1630 - 179/75 c/o increased tongue heaviness. Code yellow called at 1630. Arrived at 1635 - taken to ED. Patient reports heavy tongue and clearing of throat. No angioedema noted. Patient discharged at 2145.
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| 52 | 2021-01-22 | tongue itchiness |
Tounge started itching and raw feeling like something scalded it. Same feeling when I have somethin...
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Tounge started itching and raw feeling like something scalded it. Same feeling when I have something that has touched something I am allergic too.
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| 52 | 2021-01-24 | ear pain |
Bilateral ear pain. Treated with a course of Augmentin, Mucinex, Sudafed. No relief. Now on a 12 ...
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Bilateral ear pain. Treated with a course of Augmentin, Mucinex, Sudafed. No relief. Now on a 12 day course of Prednisone
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| 52 | 2021-01-24 | lip swelling |
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ...
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My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
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| 52 | 2021-01-24 | vision blurred | Reported blurry vision, dizziness, and severe headache. |
| 52 | 2021-01-24 | feeling of choking | Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day |
| 52 | 2021-01-24 | mouth tingling, feeling of choking |
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue...
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fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 52 | 2021-01-25 | oropharyngeal discomfort |
Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could...
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Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could breathe fine, but it felt as if it was swelling and it felt weird to swallow. I didn't want to overreact so I waited a total of 30 minutes and symptoms subsided. My throat still felt weird, but I could breathe so I felt it was fine to leave. Symptoms subsided more once I got home 30 minutes later, but I took Benadryl. Symptoms eased completely and did not return.
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| 52 | 2021-01-25 | swollen tongue |
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati...
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Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
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| 52 | 2021-01-25 | mouth numbness |
I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral fa...
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I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral facial numbness, left side greater than right side with lower lip numbness greater than upper lip numbness.
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| 52 | 2021-01-25 | loss of taste, loss of smell | Loss of Smell and Taste for about seventy two hours |
| 52 | 2021-01-26 | mouth tingling |
12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25...
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12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25mg benadryl given - patient observed 1 on 1 1:25pm patient states she can not swallow - epi pen administered per providers order 1:35pm patient states she is feeling better and symptoms are dissipating
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| 52 | 2021-01-27 | mouth tingling |
Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post ...
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Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post vaccine observation. At 0935 provider notified that customer was feeling sweaty with tingling in her tongue. Customer appears mildly flushed, calm. States that she chose to wait a little longer in the observation room because she does not ?feel right.? Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. She reports ?tingling? in the middle of her tongue and is feeling hot and diaphoretic ? different from the same menopausal symptoms that has been experiencing prior to this appointment. BP 120/78, HR 71, O2 95% RA, RR 18. Lungs CTA, RRR. Customer accepts Benadryl 50mg PO @ 0939. No rash, hives noted on exposed skin or at site of injection in left arm. Customer monitored at site. Over the course of the next 40 minutes, she reports feeling better. BP 120/70, HR 78, O2 97% RA, RR 16 @ 1022. She states that her tongue is still a bit tingly but denies feeling other worrisome symptoms she was previously experiencing. She denies feelings of facial/tongue/throat swelling, CP, SOB. Reports slight dizziness that she feels is related to Benadryl. Customer's husband (medical provider) present to drive her home. Customer states she will not be home alone. Customer aware that this provider will notify PCP Team of incident for post vaccine check in. Customer denies questions/concerns at this time. Customer released from site at 1025 ambulating independently with steady gait, no escalation of symptoms reported, no obvious s/sx of distress.
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| 52 | 2021-01-27 | mouth tingling |
Individual reported tingling in mouth and swelling in throat within fifteen minutes of receiving the...
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Individual reported tingling in mouth and swelling in throat within fifteen minutes of receiving the injection. She was given 0.5 mg of epinephrine IM at 6:57 am after having begun her observation period at 6:47. By 7:07 she reported feeling better. Tingling in mouth continued until 7:26 and then she reported it stopped. She left observation at 7:30.
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| 52 | 2021-01-27 | pain in jaw |
chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind...
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chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
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| 52 | 2021-01-31 | swollen tongue |
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest...
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Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
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| 52 | 2021-01-31 | ringing in ears |
Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Sym...
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Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Symptoms went away without intervention at 30 minutes post injection. Became short of breath with elevated heart rate and blood pressure again approx. 45 min. post injection tat worsened when standing, walking or talking, HR 143 BP 229/127 I was sent to the ED to monitor had a EKG, Benadryl, Pepcid, Then I had sinus tachycardia in ED, stayed until approx. 4 hours past injection. Symptoms resolved at time of DC
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| 52 | 2021-02-01 | mouth tingling |
Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortn...
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Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortness of breathe about 10 minutes after receiving her (second) dose of the Pfizer Covid-19 vaccine. She was then sent to the ER where she is given epinephrine IM, benadryl, steroid, PPI, fluid resuscitation, and albuterol/atrovent for her anaphylactic symptoms. She was also given zofran for her coughing and gagging symtoms. About 3 hours later, she had recovered in the ER and was discharged home.
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| 52 | 2021-02-01 | mouth discomfort, tongue discomfort |
back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of...
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back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of her mouth felt like they were burning; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 11Jan2021 10:30 AM at a single dose as COVID vaccine in a hospital. The patient had no medical history. She had no known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular in the right arm on 21Dec2020 at 11:00 AM as COVID vaccine. It was reported that on 12Jan2021-13Jan2021, the patient noticed the back of her tongue and roof of her mouth felt like they were burning, similar to eating too much pineapple. It was persistent and had not lessened. Treatment was not received for the events. She had no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the events was not recovered.
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| 52 | 2021-02-03 | mouth tingling, tongue disorder |
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ...
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Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
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| 52 | 2021-02-03 | mouth discomfort |
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu...
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Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
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| 52 | 2021-02-03 | vision blurred |
With in 20mins of vax had episode where vision were blurred. 8:30pm had another episode of blurred ...
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With in 20mins of vax had episode where vision were blurred. 8:30pm had another episode of blurred vision. Lasted 15mins then went to sleep.
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| 52 | 2021-02-03 | tongue disorder |
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac...
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allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
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| 52 | 2021-02-03 | swollen tongue |
headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat...
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headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin. Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
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| 52 | 2021-02-06 | eye swelling, eye itchiness, eye pain, bloodshot eyes | My eyes and face swelled up and my left eye has been red, itchy, and sore since then. |
| 52 | 2021-02-07 | deafness |
This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Sha...
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This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Shaking for 4 hours from about 8/9 pm to 12/1am. Nausea, vomiting, bowel pain, inflamed rectum after bowel movement the next day, loss of hearing, dizziness, Trying to sleep and waking up gasping for air about 5 times though out the early morning. Sever Headache which lasted Two and a half days. About 2 pm on 2/5/21 I took some Emetrol for the Nausea, and Tylenol for headache and fever. I took Tylenol again the evening of 2/5/21. On 2/6/21 I Tylenol and then Ibuprofen then Excedrin. On 2/7/21 I took Excedrin once and my headache was finally gone.
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| 52 | 2021-02-08 | mouth numbness |
lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from...
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lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.
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| 52 | 2021-02-09 | vision blurred |
On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry,...
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On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry, and left side of face numb by lips and jaw. She took 2 Benadryl and took a nap Thursday afternoon. She went to the ED later and was told it may be Bells' Palsy but was referred to PCP. She is on 5 mg Prednisone but rheumatologist increased dose and put on 5 day regimen. She saw PCP and he told her she had Bell's Palsy and just to follow regiment prescribed by rheumatologist.
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| 52 | 2021-02-11 | swollen tongue |
Slight swelling of back of tongue. Enough to repeatedly clear my throat. Felt like I had phlegm stu...
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Slight swelling of back of tongue. Enough to repeatedly clear my throat. Felt like I had phlegm stuck in throat and tried to clear it out. Started about 5 minutes after shot and lasted about 30 minutes
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| 52 | 2021-02-11 | ringing in ears |
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; T...
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meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 52 | 2021-02-15 | oropharyngeal discomfort |
Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headach...
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Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headache. A few hours later was dizzy and had difficulty swallowing and throat was becoming increasingly uncomfortable. Took Benadryl again and headed to hospital. Blood pressure was extremely elevated upon exam. Throat tightness became somewhat improved after Benadryl. Blood pressure improved some after taking BP med. Doctor ruled it allergic reaction to vaccine and sent me home after 5 hours with instructions to take Benadryl every 6 hours as needed.
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| 52 | 2021-02-16 | swollen tongue |
Patient has recent diagnosis of nut allergies. She denied any adverse reaction with the first vaccin...
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Patient has recent diagnosis of nut allergies. She denied any adverse reaction with the first vaccination dose. After receiving the vaccine today, the patient reported feeling like her tongue was swelling. She denied any rash or itchiness. Patient was evaluated by EMT, who placed an IV and gave IV one dose (mg not documented) of epinephrine. She was transferred to the hospital for observation.
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| 52 | 2021-02-17 | toothache |
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i...
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chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
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| 52 | 2021-02-18 | eye swelling |
Sensation of bilateral lower eye swelling without obvious signs of swelling. Sensation resolved with...
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Sensation of bilateral lower eye swelling without obvious signs of swelling. Sensation resolved without intervention. Resolved the following day, about 10 hours?
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| 52 | 2021-02-21 | lip swelling |
States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms reso...
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States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms resolved by next morning
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| 52 | 2021-02-21 | eye swelling, lip swelling |
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t...
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ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
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| 52 | 2021-02-22 | tongue disorder |
Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright ...
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Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich
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| 52 | 2021-02-23 | gaze palsy | Chills, fever( highest 101.6), headache, bad body pains |
| 52 | 2021-02-23 | burning mouth syndrome |
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal...
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Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 52 | 2021-02-23 | dry throat |
Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started...
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Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started with a sore throat, severe dryness of throat, nose, then congestion, runny nose, chills, NEVER a fever. A week later still tire, a little congestion, cough, some white liquid flem.
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| 52 | 2021-02-23 | loss of taste, loss of smell |
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (p...
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lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 04Jan2021 10:45, at single dose, for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on an unspecified date, at single dose, for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered in the hospital. 3 weeks after the 2nd dose, on 27Jan2021 the patient lost taste and smell. Her PCR nasal Covid swab was negative on 27Jan2021. The patient had not recovered from the adverse events. No treatment was received for the adverse events. Information about the lot/batch number has been requested.
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| 52 | 2021-02-24 | visual impairment |
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ...
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Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
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| 52 | 2021-02-24 | mouth numbness |
Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all ...
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Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all over, pins and needles feeling in my hands, numbness in lips ear cheek , headache neck pain. Tiredness.
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| 52 | 2021-02-24 | bloodshot eyes |
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left ar...
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I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm). I read online that this is a sign of my body fighting the vaccine and it is a good sign. I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye. My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not. She said that I needed to report my mass as it is not one of the most common side effects. I also went to the health department, where I had both shots, and had them look at the mass. They said the same thing about my body fighting the vaccine. My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine. Both of them said I needed to report this.
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| 52 | 2021-02-25 | mouth numbness | Numbness in jaw, lips, neck on left side. Tachycardia |
| 52 | 2021-02-25 | dry mouth |
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2...
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Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
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| 52 | 2021-02-25 | blindness |
Pt received the Pfizer vaccine (Pfizer Lot#:EN6200, 1st dose) at 1232 on left arm. Pt reported to le...
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Pt received the Pfizer vaccine (Pfizer Lot#:EN6200, 1st dose) at 1232 on left arm. Pt reported to lead RN that she got up and felt dizzy. Pt reported not being able to see anything for approximately 5 seconds. Pt stated that she immediately sat down. Pt stated that she has suffered from hypoglycemia in the past. Lead RN gave pt water. Pt was given a piece of candy by one of her friends in the observation area. No vital signs were taken. Pt was kept an extra 15 minutes for observation. Pt immediately started feeling better after eating candy. Lead RN reassessed pt and educated pt on s/sx that would warrant a trip to the ED. Pt stated that she was feeling a lot better. Pt left building after being observed for 30 minutes. Pt walked out of building with a steady gait.
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| 52 | 2021-02-25 | swollen tongue, eye swelling, mouth swelling | Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild |
| 52 | 2021-02-25 | bloodshot eyes, swelling around the eyes, lacrimation increased, eye itchiness, vision blurred, eye pain, eye swelling |
both eyes swollen/ one eye was swollen shut; both eyes watery; Vision is blurry; Eyes were itchy and...
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both eyes swollen/ one eye was swollen shut; both eyes watery; Vision is blurry; Eyes were itchy and painful; Eyes got very puffy; Minimal discharge; both eyes itching/Eyes were itchy and painful; both eyes red/Eyes got very puffy and very red; This is a spontaneous report from a contactable consumer. This consumer reported for 2 patients. This is the first of 2 reports. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm at the age of 52 years, on 07Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing breast cancer stage ii , mastectomy from Jun2018 to an unknown date. Concomitant medication included anastrozole (ANASTROZOLE), escitalopram oxalate (LEXAPRO) and atenolol (ATENOLOL). The patient previously took taxol and experienced drug hypersensitivity. The patient stated that this past Sunday (24Jan2021) that her daughter woke up with both eyes swollen, red, watery and itching. It was stated that they took her to the clinic and was told that this was the second one that they had seen like this. It was also stated that they gave her a prescription for eye drops. It was stated that she woke up this morning and one eye was swollen shut and wanted to know what to do or the course of action. It was stated that she was supposed to get her second shot Thursday and wanted to know if she should get her second dose or not. It was also stated that her eyes were swollen and red which were better yesterday and today are worst than they have ever been. It was stated that the left eye is more swollen than the right. It was also stated that she soaked tea bags and put them on her eyes Sunday and stated that she does not know the name of the prescription eye drops. On 17Jan2021, it was reported that the patient's eyes got very puffy and very red. Her eyes were itchy and painful with minimal discharge. Her vision was also blurry. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jan2021, sars-cov-2 test: negative on 19Jan2021 and sars-cov-2 test: negative on 25Jan2021. Therapeutic measures (Eye drops; Prednisone; Polymixin) were taken as a result of both eyes swollen/ one eye was swollen shut (eye swelling), both eyes red/eyes got very puffy and very red (ocular hyperaemia), both eyes watery (lacrimation increased), both eyes itching/eyes were itchy and painful (eye pruritus), vision is blurry (vision blurred) , eyes were itchy and painful (eye pain), eyes got very puffy (periorbital swelling) and minimal discharge (eye discharge). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106157 similar report from same reporter
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| 52 | 2021-02-27 | mouth tingling | SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS |
| 52 | 2021-02-28 | mouth numbness |
Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and b...
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Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and breathing technique - reaction resolved. Extended monitoring was provided.
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| 52 | 2021-03-01 | taste impairment, mouth tingling, eye irritation |
Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/...
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Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/30/2021). At 1029, EMT was checking in on client since she was in post vaccine waiting area for 30 min observation. EMT noticed flushed face and neck. Per client felt warm sensation and at 1031 stated metallic taste in mouth, feeling clammy with sweaty hands. PHN joined EMTs. First set of vitals: blood pressure 120/80, temperature 101.7 F. Alert and oriented, no shortness of breath, rash, itching, swelling, blurry vision, or tingling noted per client. Per client sulfa, shellfish, and contrast IV dye allergies. Medication client took this morning: Synthroid 75mcg. Clt reported she ate breakfast at 9am consisting of cereal and coffee, client reported a history of Bell's palsy 20 years ago with full recovery. 1034 temp 100.0 F. Assessed for arm drift, no tongue deviation, clt stated no tingling, able to move all extremities. 1042 vitals: blood pressure 120/100, pulse 77, o2 98, temp 99.0 F. Alert and oriented, clammy hands, no shortness of breath, no swelling. PHN offered client Benadryl, client declined. Informed client she would be kept longer for observation and client agreed. At 1047 temp 98.9 F, respiratory rate 24. At 1051 client stated tingling sensation on inner lips, metallic taste, dizziness, and mild burning sensation around eyes and nose area. PHN assessed for swelling in mouth, lips, face. PHN offered Benadryl again and client accepted. Client called husband who was in parking lot, client not driving. At 1054 Benadryl 50mg/ml IM on left deltoid. Vitals 1056: blood pressure 118/90, pulse 70, o2 98. Client informed vitals would be reassessed every 5 minutes. 1101 vitals: 99.1 F temp, blood pressure 118/78, pulse 77, o2 98. Per client dizziness and metallic taste were improving. 1106 vitals: pulse 75, o2 98, respirations 14, EMT unable to obtain blood pressure. Client complained of tingling on left index finder, PHN assessed bilateral grip strength, equal on both sides. 1114 vitals: blood pressure 128/72, pulse 74, o2 99. Per client, improvement of tingling sensation on lips, no metallic taste, no dizziness, no headache. Per client felt Benadryl effects. Vitals 1118: blood pressure 124/82, pulse 76, o2 96. Vitals 1124: blood pressure 128/78, pulse 75, o2 98. Client able to stand, denied dizziness. At 1133 noticed change in speech, slurred. Per client voice was different. called 911 at 1134. Paramedics arrived at 1142 and assumed care. Client transported to Hospital per client's husband request at 1149.
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| 52 | 2021-03-01 | vision blurred |
Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes i...
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Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes itching, red bumps, and warm to touch. I am very tired. My eyes are cloudy.
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| 52 | 2021-03-01 | eye irritation, eye itchiness, eye discomfort, dry eye |
Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 mi...
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Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 minutes after vaccination had onset of headache. Felt like a band was wrapping around right side of head, pressure over right eye, and numbness/tingling of right eye noted. No loss of vision noted, no facial drooping noted. Complained of numbness and dryness of right eye continuing at least 30 minutes after vaccination. Noted it started to burn or itch 30 minutes after vaccination.
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| 52 | 2021-03-01 | mouth numbness, swollen tongue |
Pt reported the sensation of a swollen tongue less than 10 minutes after receiving the vaccine. Exa...
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Pt reported the sensation of a swollen tongue less than 10 minutes after receiving the vaccine. Examination of the tongue did confirm this. Epi administered with relief but she then reported numbness of the lips. EMS activated and IM benadryl (difficulty gaining access) administered. Pt transported to NYU. BP noted at 132/87; HR- 99
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| 52 | 2021-03-01 | mouth tingling |
Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. B...
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Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. By 12:30 am that night my chest became itchy and I had red bumps on my chest, then around 2 pm the next day my stomach began to get itchy and red with a red bump.
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| 52 | 2021-03-02 | ear pain, mouth numbness |
Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left ar...
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Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left arm weakness or anything else. Ear pain on the left side and headache. CT Head done on 2/26/21 at ER resulting in no acute intracranial process. Diagnosed with Bell's Palsy and started on 7 days of Valacyclovir HCL 1 gram - 3 times a day and Prednisone 20mg - 3 in the morning for 5 days. Completed course of Prednisone morning of 03/03/2021. Symptoms no better with medications.
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| 52 | 2021-03-02 | swelling around the eyes |
Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash beg...
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Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash began on the nap of neck- swollen bumps. traveled around the front of the neck and then cheeks and eyes. Continued near tear ducks and all-around eye. Both eyes began to swell on 2.28 and she went to the ED for treatment. They gave her a steroid shot and benadryl IM. Discharged home, with no medications, but instructed to take benadryl as needed. She is taking benadryl every 6-8 hours for itching. She is not fully recovered due to itching and continued rash. Follow up appointment with PCP the end of this week begin of next.
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| 52 | 2021-03-02 | lip swelling, oropharyngeal discomfort |
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a...
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chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
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| 52 | 2021-03-03 | gaze palsy |
About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to chec...
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About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to check on the patient she was seizing. 911 was called. Patient's eyes were fluttering and unresponsive, but breathing. Patient came in and out of seizure a few times. 1 full body seizure about 20 to 30 seconds. Patient was laid on the ground on her side till paramedics arrived. She was then taken by ambulance.
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| 52 | 2021-03-03 | mouth numbness |
An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my...
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An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my tongue is numb. It is still numb as I type this.
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| 52 | 2021-03-03 | mouth tingling, lip swelling | Facial hives, lip tingling/swelling |
| 52 | 2021-03-04 | swollen tongue |
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021...
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At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
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| 52 | 2021-03-04 | eye discomfort |
Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one bein...
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Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one being 30 minutes after administration of vaccine, 2nd one 8 days later, and 3rd one 10 days later. Each episode lasted about 5-10 minutes. Also reports constant pressure behind both eyes.
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| 52 | 2021-03-04 | eye swelling |
Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes...
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Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes noticed eye sensitivity and headache. When symptoms did not pass after an additional 10 minutes she came back into the office. While waiting when her husband was checking her in, she "passed out." Episode lasted less than 1 minute. She was easily oriented to person, place and time. It was noted that she had some swelling to bilateral eyes. Patient was brought back to room, VS were checked and all were normal. She denied any chest pain, shortness of breath, wheezing, tongue swelling, itching, or tickling sensation to back of the throat. She was able to tolerate sips of water without difficulty. 50mg benadryl IM was given in the left deltoid. Approximately 5 minutes after IM injection patient again "passed out." She was seated at the time and slumped to her right, resting her head on her husband and did not fall from chair. She aroused after approx 2 minutes, and was a/ox4. VS were rechecked and were O2 99% on RA. HR 101, BP 124/88, RR20, temp 98.5/oral. Patient stayed at the clinic for an additional 45 minutes after which her eyesight was reported to be back to normal, her headache had improved and the lower eye edema had resolved. It should be noted that both the patient and the husband were not concerned with her "passing out." She states it happens because of pain and she was fearful of the injections. Patient also states that her neurologist told her that when "she is in too much pain, she will pass out."
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| 52 | 2021-03-06 | swollen tongue, mouth numbness |
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i...
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After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
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| 52 | 2021-03-07 | ringing in ears, visual impairment |
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,...
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03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
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| 52 | 2021-03-07 | eye irritation, swelling of eyelid |
Patient reported mild fatigue and arm soreness until the following afternoon when her left eye bega...
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Patient reported mild fatigue and arm soreness until the following afternoon when her left eye began to burn which progress to the right eye. Later in the evening the left upper eye lid began to swell extending into the lower lid along with right upper lid swelling. She contacted medical through our COVID hotline where I was notified around 9 pm Thursday night ( 03/04/2021). She denied an respiratory or cardiac symptoms and was mostly concerned about the periorbital edema. She did not feel she needed to go to the hospital. She was advised to take Benadryl 50 mg every 6-8 hours and apply cold packs. A follow up call was made by me at 07:30 am on Friday and was instructed to contact her PCP. Later that day she called me indicating she went to Urgent Care and was seen by Dr.
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| 52 | 2021-03-08 | ear pain |
I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt q...
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I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt quite a bit. My arm started hurting right away. Over the course of the afternoon, I felt achy and tired. I went to bed about 9:30 pm. During the night I suffered nausea, headache (on the left side), bad chills and then sweats. Fever of 102.4. Arm so sore can even sleep on it. By the am, 10:20 am, still massive fatigue, aches, fever (still between 100.9 and 102.4), chills and earache. .
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| 52 | 2021-03-09 | ringing in ears |
The evening after the vaccination I began to have a constant, high frequency ringing in my ears. I ...
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The evening after the vaccination I began to have a constant, high frequency ringing in my ears. I know it's not a big or deadly reaction, but it's nearly a week later and it has not abated. I would not be concerned about it if I thought it was temporary, but it is bothersome and not going away. I have never had any kind of trouble with tinnitus before, but interestingly, my sister has had trouble with it much of her adult life. I do not know if that's important, but the fact is I am a bit worried about the second dose and it being worse or causing it to continue. I hope it did not trigger a long term problem. Still, I am glad to have had it. I have had no other obvious reactions to the vaccine.
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| 52 | 2021-03-09 | mouth tingling, eye irritation, mouth numbness |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | oropharyngeal discomfort |
patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discu...
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patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discussed vaccine and she was happy to get it. After giving her her dose, she called nurse over to say that she didn't feel well. Patient continued to state that her throat felt weird, she felt like throwing up, it was hard to swallow, and that she was sweaty. She said she had a nervous cough. At 10:20 Am we checked her BP - it was 141/115 and her pulse was 63. She asked for epipen but didn't truly need at the time - said her breathing was fine. At 10:31 Am her pulse was 59 and BP 128/84. She got an ice pack after offering a couple times at 10:31. 911 Was called at 11:05 Am because patient still stated she didn't feel right.
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| 52 | 2021-03-09 | visual impairment |
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ...
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she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-10 | oropharyngeal discomfort |
APPROX 15 MIN AFTER TAKING THE VACCINE, ON 03/10/2021- I ATTEMPTED TO DRINK WATER , DIFFICULT TO SWA...
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APPROX 15 MIN AFTER TAKING THE VACCINE, ON 03/10/2021- I ATTEMPTED TO DRINK WATER , DIFFICULT TO SWALLOW, BUT ABLE TO SWALLOW, TOOK BENADRYL BY MOUTH 25MG OTC, DIFF SWALLOWING CONTINUES, NO DIFFICULTY BREATHING BUT SWALLOWING DIFFICULT ALMOST LIKE SOMETHING WAS IN THE BACK OF MY THROAT, NOT PAINFUL. APPROX 20 MINUTES AFTER BENADRYL, SYMPTOM IMPROVED. APPROX 1 HOUR LATER IT RESOLVED. TODAY 03/11/2021 , HEADACHE AND BODY ACHES TOLERABLE-NO PROBLEMS SWALLOWING
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| 52 | 2021-03-10 | ringing in ears |
At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhe...
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At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhea and headache and continue ribgibg4in my ears into Thursday and
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| 52 | 2021-03-11 | ringing in ears |
1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitch...
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1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitched sound. began intermittently, then progressed to continuous. 2. PERIPHERAL NEUROPATHY (tingle/numbness) - bilateral, hands and feet: began intermittently, then progressed to continuous.
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| 52 | 2021-03-11 | swollen tongue |
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stat...
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Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
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| 52 | 2021-03-11 | mouth swelling |
Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. ...
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Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. Patient received Epinephrine 0.3 ml of 1 mg/ml solution IM, plus benadryl 50 mg p.o. Patient was transported to ED.
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| 52 | 2021-03-11 | mouth tingling |
Received first dose of COVID vaccine on 1/23/21. Complicated by itching and tongue pain. No rash o...
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Received first dose of COVID vaccine on 1/23/21. Complicated by itching and tongue pain. No rash or tongue swelling. Given dexamethasone and Benadryl. Got second dose of COVID vaccine on 3/4/21 followed 45 minutes later by SOB, lightheadedness and mouth tingling. No rash or tongue swelling. Rx steroid + saline with resolution. ED visit.
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| 52 | 2021-03-12 | tongue disorder |
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse...
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10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling, I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml, I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
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| 52 | 2021-03-12 | lip itchiness, mouth itchiness, mouth tingling |
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f...
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15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
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| 52 | 2021-03-13 | eye pain |
Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss...
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Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss of appetite,
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| 52 | 2021-03-13 | mouth tingling, lip swelling |
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ...
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Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
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| 52 | 2021-03-13 | visual impairment |
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va...
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This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
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| 52 | 2021-03-13 | ringing in ears |
Tinnitus. A constant ringing/buzzing in head that has lasted from the initial vaccine. I have not ...
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Tinnitus. A constant ringing/buzzing in head that has lasted from the initial vaccine. I have not sought treatment but am convinced it was from the vaccine as the symptom began the same night of administration.
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| 52 | 2021-03-16 | mouth itchiness |
Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair...
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Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair - lower right leg hot and tightness and a little weak both legs, but right was more severe Itch mouth got better with Benadryl. I had not issues breathing or swelling. It wasn't bad, just annoying. By day 5, I was back to normal.
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| 52 | 2021-03-16 | mouth tingling |
Patient monitored for thirty minutes per protocol of having multiple drug allergies. Patient had n...
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Patient monitored for thirty minutes per protocol of having multiple drug allergies. Patient had no history of anaphylaxis. Patient left clinic and while in car ( being driven by sister in law) experienced tingling in the roof of her mouth. 50 mg. of Benadryl was administered by mouth per standing orders.
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| 52 | 2021-03-16 | mouth numbness |
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ...
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Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
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| 52 | 2021-03-16 | swollen tongue | Swelling of tongue and throat |
| 52 | 2021-03-17 | oropharyngeal discomfort |
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper...
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ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
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| 52 | 2021-03-17 | vision blurred | Dizziness, mild headache to right side of head, blurry. |
| 52 | 2021-03-17 | eye itchiness |
Symptoms: itchy eyes, nose, throat - the same symptoms she reports when she starts to have an allerg...
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Symptoms: itchy eyes, nose, throat - the same symptoms she reports when she starts to have an allergy to Shellfish. Time course: started a couple minutes post-vaccination, lasted for only about 10 minutes. Immediately started improving upon administration of Benadryl.
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| 52 | 2021-03-17 | mouth tingling, mouth itchiness | itchy mouth, lips tingling & mouth |
| 52 | 2021-03-17 | mouth tingling, mouth numbness |
started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives ...
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started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives and difficulty breathing. EMS administered benadryl, solumedrol, and epinephrine and transferred to ER. She responded to treatment quickly and was discharge from the ER same day.
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| 52 | 2021-03-18 | loss of smell, loss of taste |
1/31/2021 patient developed chills, cough, loss of taste/smell, nausea, vomiting, sore throat. posi...
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1/31/2021 patient developed chills, cough, loss of taste/smell, nausea, vomiting, sore throat. positive for COVID
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| 52 | 2021-03-18 | swollen tongue |
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue...
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Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
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| 52 | 2021-03-18 | swollen tongue, ear pain, lip swelling |
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; l...
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Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.
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| 52 | 2021-03-18 | mouth tingling | dizziness and tongue tingling. Evaluated by EMS-Cleared |
| 52 | 2021-03-18 | mouth numbness, mouth tingling |
patient experienced light headedness and numb or tingling feeling on tongue immediately following va...
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patient experienced light headedness and numb or tingling feeling on tongue immediately following vaccination
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| 52 | 2021-03-20 | double vision |
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability t...
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SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
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| 52 | 2021-03-20 | ringing in ears | Sporadic Tinnitus (not loud) and sensation of small bubbles in back of throat |
| 52 | 2021-03-22 | hearing loss, bloodshot eyes, eye pain, eye irritation |
Earrs: Swollen Eustachian tubes in both ears: distorted hearing, amplified sound, equilibrium off....
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Earrs: Swollen Eustachian tubes in both ears: distorted hearing, amplified sound, equilibrium off. Eyes: both eyes had irritation, then Left eye pain, inflammation and redness on the outer edge of eyeball.
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| 52 | 2021-03-22 | mouth tingling |
Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and ba...
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Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and back at 12:41 pm and given Benadryl 25 mg x 1 Dose. Patient started developing tingling lips at 12:50 pm and received EpiPen 0.3 mg x 1 dose and EMS was called. Blood pressure at 122/89 at 12:55 pm; 142/87 at 12:58 pm. Patient was taken to hospital for evaluation.
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| 52 | 2021-03-22 | eye pain | Soreness at injection site, mild fatigue, headache, soreness in eyes |
| 52 | 2021-03-22 | ringing in ears |
Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular u...
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Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular use cuff and was 210/175 and tinnitus used to wax and wane in past but no problems, and this acute on chronic onset was severe, 24/7, non-stop and interferes primarily with sleep. Very loud non-stop bilateral tinnitus. I treated elevated BP for 2 weeks with Losartan 25 mg qd, then daily BP came back to normal and Losartan stopped. Tinnitus has not changed.
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| 52 | 2021-03-22 | mouth tingling | Tingling to tip of tongue and bottom lip. |
| 52 | 2021-03-22 | mouth tingling, mouth numbness |
Within 10 minutes of vaccine administration, pt began to experience tongue "fullness" and lip numbne...
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Within 10 minutes of vaccine administration, pt began to experience tongue "fullness" and lip numbness. Progressed to tongue numbness. VSS and lungs clear. Benadryl given with relief of sx's in 20 minutes.
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| 52 | 2021-03-24 | bloodshot eyes, eye irritation, vision blurred |
Caller experienced fatigue within 2 hrs of rcvding the vaccine on 3/23/2021, and she experienced mil...
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Caller experienced fatigue within 2 hrs of rcvding the vaccine on 3/23/2021, and she experienced mild body achiness within 24 hrs of rcvding the vaccine. The fatigue and mild bod yachiness has subsided. Upon waking this morning on 3/24/2021, she have the following symptoms in her left eye: redness, runny, burning sensation and blurry vision.
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| 52 | 2021-03-24 | swollen tongue |
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re...
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Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
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| 52 | 2021-03-24 | oropharyngeal discomfort | Scratchy throat 10 minutes after injection |
| 52 | 2021-03-25 | mouth tingling, vision blurred, ear discomfort, mouth numbness |
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l...
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Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
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| 52 | 2021-03-25 | mouth tingling |
Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster...
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Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster and my lips began to tingle. The nurse gave me 25 mg of Benadryl and I also am experiencing itching all over my body.
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| 52 | 2021-03-25 | lip swelling, swollen tongue |
Later the day of her shot, she reports that her tongue and lips became swollen and she had difficult...
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Later the day of her shot, she reports that her tongue and lips became swollen and she had difficulty breathing. She stated that "I felt exactly how I feel when I'm around shellfish." I advised her to see her MD and to not receive the second dose of the vaccine.
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| 52 | 2021-03-25 | swollen tongue, burning mouth syndrome |
Tongue pain with swelling, blistering & white coating; blisters inside cheeks;slight headache; sore ...
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Tongue pain with swelling, blistering & white coating; blisters inside cheeks;slight headache; sore throat; fatigue
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| 52 | 2021-03-26 | ringing in ears |
Constant buzzing in head, tinnitus. Everyday. Loudest when lying down and at night. Doctor said to...
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Constant buzzing in head, tinnitus. Everyday. Loudest when lying down and at night. Doctor said to take Flonase and Zyrtec . Has not helped.
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| 52 | 2021-03-26 | tongue itchiness, dry mouth |
First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right pa...
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First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right palm - Itchy and dry to the point of not able to sleep. On some days itchy tongue too. Going to see a doctor on March 30th.
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| 52 | 2021-03-26 | mouth numbness | Severe numbness in the left side of face , tongue, mouth ,ear neck, arm and foot. |
| 52 | 2021-03-28 | eye swelling | Both eyelids are swollen. Left eyelid is more swollen then right. |
| 52 | 2021-03-28 | ear pain |
Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started havin...
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Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started having pain in/behind left ear. This continued up to the time when on 3/24/2021 at 6:45AM my left eye was blinking slower than the right eye and the left-side of my mouth showed signs of drooping. I was admitted to the ER for possible stroke due to symptoms I was having but test results showed Bell?s Palsy. Treatment is acyclovir, ketorolac, prednisone and artificial tears ointment
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| 52 | 2021-04-04 | hearing loss, ringing in ears |
Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-exist...
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Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-existing tinnitus in my left ear, which has been stable and very mild for 35+ years, suddenly spiked to an almost unbearable level. It has remained consistently high ever since. New tinnitus symptoms presented in my right ear at the same time. I also experienced a sudden decline in my hearing acuity. I additionally experienced tingling and muscle weakness in my face, which has since resolved. However the severe tinnitus remains.
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| 52 | 2021-04-08 | swollen tongue |
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu...
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Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
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| 52 | 2021-04-17 | deafness unilateral |
Approximately 1 week after my vaccination, I began losing hearing in my right ear. Coincidentally t...
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Approximately 1 week after my vaccination, I began losing hearing in my right ear. Coincidentally the same side I received my vaccination; This is a spontaneous report received a contactable consumer, the patient. A 52-year-old adult [non-pregnant] female received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 25Mar2021 at 13:30 (at 52-years-old), for COVID-19 immunisation. Relevant medical history included depression. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and sulfamethoxazole/ trimethoprim (BACTRIM). The patient previously received treatment for an unspecified indication with codeine and experienced a drug allergy. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 29Mar2021 she began to lose hearing in her right ear. The patient noted that it was coincidentally the same side that she received the vaccine on. The event did not result in any visit to an emergency room, physician office or hospital. It was unknown if any treatment was received. The outcome of the event began to lose hearing in her right ear was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 52 | 2021-04-20 | ringing in ears |
Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 5...
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Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Mar2021 10:30 (Batch/Lot Number: EN6205) at the age of 52 years old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bilateral tinnitus on 12Mar2021 19:15. Event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result included Hearing test and ENT visit. Outcome of event was not recovered.
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| 52 | 2021-04-23 | pain in jaw |
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e...
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All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
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| 52 | 2021-04-28 | deafness unilateral |
hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient...
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hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient, and a non-contactable consumer, the patient's sister. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 23Mar2021 between 13:00 and 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history includes ringing in ears, problem with hearing out of the other (left) ear. Concomitant medications were none. There were no additional vaccines administered on the same date, or within 4 weeks of BNT162B2. On 24Mar2021, the patient experienced hearing loss in the right ear and sometime between 19:00 - 20:00, the patient could not hear out of the right ear for a day. The patient never had a problem with this ear. No emergency room or physician's office visit was required. The patient got up the next morning and her hearing was back. The clinical outcome of hearing loss in the right ear and could not hear out of the right ear was resolved on 25Mar2021. Information on the lot/batch number has been requested.
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| 52 | 2021-04-30 | deafness |
After 24 hours hearing in left ear was diminished and has not resolved.; This is a spontaneous repor...
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After 24 hours hearing in left ear was diminished and has not resolved.; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization (Age at vaccination: 52 years). Medical history was reported as none. The patient's concomitant medications were not reported. On 07Apr2021, 08:00, after 24 hours hearing in left ear was diminished and has not resolved. The patient did not received any treatment for the event. Patient was not pregnant The patient did not have COVID prior vaccination. The patient did not test for covid post vaccination. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-05-07 | ear pain, ear discomfort, ringing in ears, hearing loss |
excruciating pain in her ear; left ear completely filled up and got completely full; Hissing and tin...
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excruciating pain in her ear; left ear completely filled up and got completely full; Hissing and tinnitus worsened; low grade fever (100.2°F); Couldn't hear; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8734), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Medical history included labyrinthitis on 2017 to an unspecified date where her left ear became blocked up and had to have her ear cleaned up and experienced severe vertigo and dizziness, swimmers ear in her left ear on an unknown date several years before and afterward just her left ear would get clogged up, low grade tinnitus from 2017 and ongoing. The patient was taking unspecified birth control tablets since 2015 and ongoing for an unknown indication (reported as 'to regulate') which she was off of for a couple of years but had to be put back on because of a pretty intense experience (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID vaccine. The patient previously got a flu shot on an unknown date, maybe once in the last 10 years and expeirenced flu symptoms. All her other vaccines were when she was a kid. The patient was not a believer of western medicine or vaccinations since medications just poison other things in the body. The patient reported that one week after the first dose of the COVID-19 vaccine, on 02Apr2021, her left ear completely filled up and got completely full. The patient couldn't hear on Apr2021. Her hearing was blocked and she started running a low grade fever (100.2°F) on Apr2021. The patient had excruciating pain in her ear on 02Apr2021 and her ear pain was at a 10 on an unknown date in Apr2021. She added that she has a high pain tolerance and that she is not a baby. She could not get her ear to clear by herself and she could not get her ear to pop in the shower. She went to urgent care, and the provider cleared her ear with a syringe. The urgent care provider cleared the fluid in her ear with the syringe and cleared out ear wax. She thinks that this was an immune response to the Covid-19 vaccine. The patient added that the hissing noise and tinnitus worsened in her head and has been enhanced on 02Apr2021, since she received the first dose of the COVID-19 vaccine. It took another week and a half for her ear pain and fever to resolve. The urgent care provider prescribed her amoxicillin to take. Her pharmacist informed her that if her fever did not stop in 2 days then she did not have an infection and did not need the antibiotics and if she still had a fever after 2 days of taking the amoxicillin, the patient's symptoms were a delayed reaction to the COVID-19 vaccine. She took the amoxicillin and her fever finally broke, her ear pain resolved, but the tinnitus and hissing in her head is louder than it was before she received the first dose of the COVID-19 vaccine. The patient talked to a physician who is at a location administering the Covid-19 vaccine and the physician informed her that she was not crazy and she did not need amoxicillin. The physician stated that he has been seeing and hearing from people getting the COVID-19 vaccine that they are experiencing ear fullness, low grade fever, and ear pain. The patient reported that her concern is getting the second dose of the COVID-19 vaccine. She is concerned that her tinnitus is going to get worse with the second dose of the COVID-19 vaccine. She knows that the vaccine is all new and is for emergency use and she doesn't know what to do. She did want to report what happened to her. She found a support group for those experiencing tinnitus after receiving the COVID-19 vaccine. She was not alone as there are over 1,000 people in the support group. The number of people experiencing tinnitus is relatively low because there have been over 80 million vaccinated. She had her first dose of the COVID-19 vaccine 4 weeks ago, 26Mar2021 and the pharmacist said that the patient could not get the second dose of the COVID-19 vaccine while she was running a fever. The pharmacist informed her that she could hold out on getting the second dose of the COVID-19 vaccine for 6 weeks. She is worried about her ear and the tinnitus and what could potentially happen with the second dose of the COVID-19 vaccine. The people in the support group were saying that the tinnitus is worsening with the second dose of the COVID-19 vaccine. She does not want to live with worsening of the tinnitus, so she needs that answered. For the pain she was experiencing, the patient stated that for her to go buy ibuprofen and risk taking ibuprofen because she knows the side effects for that, she has to be in a lot of pain so she doesn't take anything. She takes natural remedies and for her to go to the pharmacy to get Advil, you have to know she is in a lot of pain. The patient does not have a thermometer so she does not know when her fever started in Apr2021. She stated that it was weird and she felt awful and that she for sure had a low grade fever that whole week. She is still experiencing a small amount of ear pain. The hissing and tinnitus worsened through the whole thing. The patient reported that when her ear filled up and she was having excruciating pain, the hissing got worse. She did not have her hearing tested but once the urgent care provider syringed the fluid from her ear, she felt like her hearing was normal. The patient said she had a hearing test in 2017 that was fine. The physician told her that she was going to have tinnitus, but that the patient would habituate to it and it would get to the point where the tinnitus was not so irritating. She knows that the ear fullness was an immune response. She added that it seems like the COVID-19 vaccine is going for weak areas and triggering a response. The outcome of the events left ear completely filled up and got completely full and couldn't hear was recovered on 06Apr2021 and the event low grade fever was recovered on Apr2021. The event excruciating pain in her ear was recovering the event hissing and tinnitus worsened was not recovered.
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| 53 | 2021-01-03 | hearing loss |
At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minut...
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At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.
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| 53 | 2021-01-03 | oropharyngeal discomfort |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | lacrimation increased, sensitivity to light |
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende...
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I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
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| 53 | 2021-01-03 | tongue disorder |
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu...
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Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
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| 53 | 2021-01-04 | mouth tingling | Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB |
| 53 | 2021-01-04 | taste impairment |
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ...
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Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-04 | ear pain, pain in jaw |
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s...
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a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
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| 53 | 2021-01-04 | visual impairment, vision blurred |
blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a conta...
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blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included eyeglasses wearer (reported as with her glasses). The patient's concomitant medications were not reported. The patient is experiencing symptoms from the COVID-19 vaccine received on 18Dec2020. She began to have blurred vision that night, and it worsened over the following weekend. She saw the eye doctor on 22Dec2020, and they stated her vision had changed even with her glasses. Now she has little spots on the inside of her eyelids that were also noticed on the eye examination in Dec2020. She has already reported these symptoms to the V-safe program. She mentioned that she is not the only nurse in the workplace that has experienced blurry vision. She asked if she should receive the second dose on 08Jan2021. It was still blurry, but it was better than it was a week ago. It still affected her reading and seeing at a distance. It scared her to get the second one because she doesn't want to go blind. She went to the eye doctor for visit on Tuesday. The outcome of the event blurred vision was recovering, while for the other event was unknown. The reporter considered blurred vision as serious due to being medically significant. Information about lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that the reported event vision blurred and eyelid disorder related to the suspect product event most likely due to patient underlying contributory factors
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| 53 | 2021-01-04 | mouth tingling |
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th...
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feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
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| 53 | 2021-01-05 | lacrimation increased |
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m...
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FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
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| 53 | 2021-01-05 | loss of taste |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-05 | visual impairment |
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi...
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associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
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| 53 | 2021-01-05 | loss of taste, loss of smell |
loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous re...
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loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events. Information on the batch/lot number has been requested.
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| 53 | 2021-01-06 | swollen tongue |
Started having tongue swelling about 1 hour after injection, treated myself at home with Benadryl. A...
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Started having tongue swelling about 1 hour after injection, treated myself at home with Benadryl. Around midnight increased tongue swelling, throat tightness and shortness of breathe. Went to emergency room and treated with epinephrine, steroids, Benadryl, Pepcid and required a nebulizer (duoneb). Discharged home from ER with prescription s for Prednisone, Pepcid and Benadryl
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| 53 | 2021-01-07 | oropharyngeal discomfort |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% Â At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-08 | taste disorder |
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes...
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1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
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| 53 | 2021-01-08 | eye itchiness, dry throat |
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note...
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Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
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| 53 | 2021-01-10 | swollen tongue |
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (t...
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(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
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| 53 | 2021-01-10 | lip swelling |
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, ...
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At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.
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| 53 | 2021-01-11 | pain in jaw |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | dry mouth, taste impairment |
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug...
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Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
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| 53 | 2021-01-11 | ringing in ears |
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (histor...
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Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
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| 53 | 2021-01-11 | sensitivity to light |
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo...
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Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
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| 53 | 2021-01-12 | ear discomfort |
12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressur...
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12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressure was 180/117 and husband took her to the hospital.
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| 53 | 2021-01-12 | mouth discomfort |
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j...
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Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
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| 53 | 2021-01-13 | taste impairment |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-13 | ear swelling |
Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very...
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Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very itchy. On Sunday I had hives on my upper legs, stomach, buttocks and my ears were swollen and purple. went to urgent care 1/2/2021. Gave me prednisone 40mg for 5 days and triamcinolone cream.
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| 53 | 2021-01-13 | sensitivity to light, extreme sound sensitivity |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-14 | taste impairment, dry mouth |
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in...
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fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-16 | mouth numbness, swollen tongue |
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower...
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I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
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| 53 | 2021-01-16 | mouth tingling |
Mild tingling on upper lip lasting 24 hrs- thought it was a herpes prodrome , took valcyclovir 1000 ...
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Mild tingling on upper lip lasting 24 hrs- thought it was a herpes prodrome , took valcyclovir 1000 mg x1. This was unusual because I don?t ever get tingling in upper lip , I only get cold sores occasionally on lower lip, so then I realized after talking with my coworkers, it was probably a vaccine reaction and I shouldn?t have taken the Valcyclovir
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| 53 | 2021-01-16 | loss of taste, loss of smell |
Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sa...
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Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sat at work she couldn't taste or smelled food. Took covid test, +for covid on 1/2/21. On 1/13/21 had another covid test it was negative. Congestion, h/a cough. Feels better and report back to work 1/18/21.
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| 53 | 2021-01-16 | swollen tongue |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-17 | ringing in ears | Constant ringing in ears |
| 53 | 2021-01-18 | loss of taste |
Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This...
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Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 18Dec2020 at single dose in right arm for covid-19 immunization. Medical history included hypertension and anxiety. No other vaccine was received in for weeks. Concomitant medications in two weeks included losartan, famotidine, aspirin (acetylsalicylic acid), prazosin, escitalopram. The patient did not have COVID prior vaccination and patient did not underwent COVID tested post vaccination. The patient experienced low-grade fever, severe joint/muscle aches, headache, loss of taste on 19Dec2020 01:00. The patient did not receive any treatments of the events. The outcome of the events was recovered on an unspecified date. Information on Lot/Batch has been requested.
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| 53 | 2021-01-18 | bloodshot eyes |
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done...
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Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done. received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck. Also sore throat, red throat, headache, nausea, and diarrhea. Doctor prescribe antibiotics and Norco. Stomach pain returned 12/31.
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| 53 | 2021-01-18 | loss of taste, loss of smell |
She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and c...
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She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and contracted COVID/tested positive after getting the 1st dose; Tested positive after getting the 1st dose; She returned home with sniffles, fatigue, and no taste/She had sniffles and post nasal drip; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, exp date not reported), via an unspecified route of administration on 19Dec2020 for given since patient works with COVID patients (COVID-19 immunisation). The patient had no relevant medical history. There were no concomitant medications. Nurse called asking if she can get the 2nd dose of the vaccine 6 days after the 21st day. She tested positive on 05Jan2021 after getting the 1st dose and was still in quarantine. The nurse works at a hospital. She received her first dose of the COVID-19 Vaccine on 19Dec2020, and afterwards donated blood on the same day. She got the vaccine through her place of work. She said when she donated blood on 19Dec2020, her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies. She lives about 30 mins from work, so she thought she would get both done in the same day. She gave blood right before she got the vaccine. She gave the blood then went and got the Vaccine. She said on 26Dec2020 she went to Entertainment complex as it was her vacation. Her and her family went for 4 days. On 30Dec2020 she returned home with sniffles, fatigue, and no taste. She said she tested positive for the COVID-19 Virus on 05Jan2021. On 30Dec2020 they got back, and on 02Jan2021 she had sniffles and post nasal drip. On 03Jan2021 she did not wanna get out of bed. She was profoundly fatigued. She also lost her smell. She had to go back to work on 07Jan2021, but did not want to go back in unless she was sure she was okay because she works with babies. She had no other symptoms after 03Jan2021, except no smell and no taste. She got tested for COVID and was positive on 05Jan2021 (also reported as 06Jan2021 [pending clarification]). Her and her husband were both positive, but her kids were not. The weird thing was she also on 06Jan2021 got her results back from giving blood and she was negative for COVID on 19Dec2020 prior to getting the vaccine. Caller clarifies that her COVID test was a nasal swab. Patient thought her age may have contributed to her feelings of fatigue. She had indicated she worked in either a hospital NICU or nursery, and that is why she had to quarantine for 14 days. She probably would not have even gotten tested for COVID if she was not a nurse and did not know that losing taste and smell were a sign. She feels fine. She said she was scheduled for her second dose of the COVID-19 Vaccine on 12Jan2021. She said she was now in quarantine for 14 days due to testing positive for the COVID-19 Virus, and her quarantine period ends on 14Jan2021. Since now she is in quarantine, she will miss her second dose which was supposed to be on 12Jan2021. She said she rescheduled her second dose of the COVID-19 Vaccine to 18Jan2021, which was 6 days later than when she was supposed to receive the 2nd COVID-19 Vaccine dose. She asked if getting the dose 6 days late was okay. The events were considered as non-serious by the reporter. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-01-18 | swollen tongue, burning mouth syndrome |
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing,...
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right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
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| 53 | 2021-01-19 | vision blurred |
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The...
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Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
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| 53 | 2021-01-21 | feeling of choking |
Approximately five minutes of receiving the second vaccine broke out in hives everywhere started exp...
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Approximately five minutes of receiving the second vaccine broke out in hives everywhere started experiencing throat tingling. Was taken to ER. I am a nurse at hospital Was given Solu-Medrol and Benadryl IV in ER
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| 53 | 2021-01-21 | oropharyngeal discomfort |
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill...
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First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
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| 53 | 2021-01-21 | oropharyngeal discomfort | HAD BODY ACHES, SCRATCHY THROAT, HEADACHE AND FEVER OVERNIGHT |
| 53 | 2021-01-21 | mouth tingling, mouth numbness |
Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after ...
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Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after sx started. This injection, sx started earlier. No soa, itching, throat tightness or distress. Pt numbness and tingling resolved and then returned with some throat numbness. Pt remained without distress and after observation period opted to be dismissed and no er visit, called for ride, stated sx almost resolved at time of dismissal, no distress. Dismissal vs- 117/83 bp 79 hr 98% sao2
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| 53 | 2021-01-21 | oropharyngeal discomfort |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-23 | ringing in ears |
I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternati...
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I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternating chills and sweating - did not take temp), global muscle and joint aches and pains, abdominal pain, a feeling of exhaustion, pounding headache, and ringing in my ears. While most symptoms resolved with a dose of acetaminophen followed a few hours later with a dose of ibuprofen by 1600 the same day, the tiredness and abdominal pain lingered for four days, and the ringing in the ears is remaining persistent. The ringing has not yet ceased (today is day five post vaccination).
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| 53 | 2021-01-23 | taste impairment |
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started...
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Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
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| 53 | 2021-01-24 | bloodshot eyes |
I called facility to check on everyone and see how they felt, and pt stated that her eyes looked ver...
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I called facility to check on everyone and see how they felt, and pt stated that her eyes looked very very red. She me a pic which I shared with. She has a burning sanitation and she bought over the counter eye drops.
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| 53 | 2021-01-24 | loss of taste, loss of smell |
Near complete loss of taste and smell.; Near complete loss of taste and smell.; This is a spontaneou...
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Near complete loss of taste and smell.; Near complete loss of taste and smell.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at left arm on 08Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included anxiety and depression, both from an unknown date and unknown if ongoing. The patient's concomitant medication included lamotrigine, fluoxetine, rheum rhaponticum root (ESTROVERA) and gabapentin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at right arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. On 11Jan2021 at 14:30, the patient experienced near complete loss of taste and smell. The patient underwent lab tests and procedure which included SARS-COV-2 antibody test (Nasal swab): negative on 11Jan2021. The patient outcome of the events was not recovered.
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| 53 | 2021-01-24 | mouth tingling |
my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Pr...
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my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Professional reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided, expiry date unknown) via an unspecified route of administration in the left arm at single dose on 23Dec2020 at 15:30 for COVID-19 immunization. The patient had allergy to codeine. Concomitant medications included metformin, atorvastatin, vortioxetine hydrobromide (TRINTELLIX), insulin glargine/lixisenatide (SOLIQUA). The patient reported that her first dose of the vaccine caused tingly lips. Onset date and outcome of the event were not reported. Information about lot/batch number has been requested.
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| 53 | 2021-01-25 | mouth tingling, taste impairment |
At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing s...
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At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing sensation from head to toe and tingling in lops. Vital signs taken at 1:50pm 158/92, pulse 71, resp 20, 1:55pm: 138/64, pulse 62, 2:05pm: 112/70, pulse 60, 2:15pm: 110/72, pulse 59, 2:28pm: 130/70, pulse 60, 2:40pm: 128/74 pulse 60, resp. 18. O2 sat remained 96-99% on room air. After 45 minutes patient reported feeling better and left with family member. Instructed to self monitor and to contact MD or report to ER if symptoms return or worsen. Patient verbalized understanding. Patient received Pfizer BioNTech Covid 19 vaccine EUA.
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| 53 | 2021-01-25 | eye swelling |
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches....
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Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
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| 53 | 2021-01-25 | oropharyngeal discomfort, mouth tingling |
Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her t...
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Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her throat, tingling of lips and tightness on her throat. Dr. was immediately called. Orders for Benadryl 100 mg IM was given and medication was administered on right gluteus. Vital signs were taken and recorded on chart. Patient was monitored and verbalized improvement within 5 minutes of adminstration. Patient was monitored for another 30 minutes. Patient stated that she was feeling better.
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| 53 | 2021-01-25 | taste impairment |
within 15 minutes of receiving my injection, I experienced a strong metallic taste in my mouth that ...
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within 15 minutes of receiving my injection, I experienced a strong metallic taste in my mouth that lasted constantly for a week after my injection. I am still occasionally experiencing an intermittent metallic taste, that dissipates quickly,. I am scheduled for my second injection this evening.
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| 53 | 2021-01-26 | swelling of eyelid |
On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, p...
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On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, pt developed swelling of eyelids, lightheadedness and nasal congestion. Pt reported similar symptoms related to seasonal allergies which she also experiences at this time of year. Pt self-medicated with fexofenadine (Allegra). Pt notified primary care provider. Pt denied any shortness of breath, difficulty swallowing or rash. Pt was advised to take diphenhydramine 50 mg. In no improvement in swelling, pt was advised to go to urgent care.
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| 53 | 2021-01-26 | ear swelling | Systemic: left ear swelling at 40 minutes; symptoms lasted 1 day |
| 53 | 2021-01-26 | mouth tingling |
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ...
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dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
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| 53 | 2021-01-27 | loss of smell, loss of taste |
12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) l...
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12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) lightheaded and some pruritis, although patient continued with work (rounding on service). Self treated with tylenol. She noted two spots on her left arm (pictures emailed to me), self-treated with motrin. 12/29 in the arm she believed the spots on her left wrist were more pronounced, with new spots on her forearm. Round maculopapular back left of spine 12/19 in am. Self treated with claritin. Called the reaction line and evaluated by Dr. on Thursday as all symptoms progressed. Simmered down over the weekend. Last claritin or any antihistamine was 6 days ago. Had COVID with positive PCR in April 2019. Still with positive antibodies, measured repeatedly as part of participation in program. Persistent loss of taste and smell. No history of known miralex exposure. Has not had a colonoscopy before. Minimal use of personal care products/lotions. Received annual flu vaccine without complications. Never history of anaphylaxis. Allergic reaction to COVID19 vaccine with diffuse cutaneous symptoms; not classical IgE mediated reaction No evidence of clear anaphylaxis to COVID-19 vaccine (or any other injectable). Patient received their second dose of vaccine on 1/19 - 30 minutes of monitoring instead of 15 minutes.
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| 53 | 2021-01-27 | ringing in ears | Bilateral Tinnitus |
| 53 | 2021-01-27 | swollen tongue |
reports she received the 2nd dose of Covid vaccine on 1/27 at 1430 and started having fever 100.8-1...
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reports she received the 2nd dose of Covid vaccine on 1/27 at 1430 and started having fever 100.8-100.9 and HA, swollen tongue, around 1/27 2100.
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| 53 | 2021-01-28 | dry throat |
1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a s...
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1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a steriod shot (methylPREDISolone (Medrol (pak)) and I was given famotidine (Pepcid pill). A prescription was called into my pharmacy (famotidine and methylPREDNISolone)
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| 53 | 2021-01-28 | eye discomfort, vision blurred |
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl...
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Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
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| 53 | 2021-01-28 | tongue disorder | FEVER, "THICK TONGUE", LOWER BODY ACHES |
| 53 | 2021-01-28 | blindness |
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ...
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lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-28 | loss of smell, loss of taste |
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh...
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she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
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| 53 | 2021-01-30 | lip swelling | developed swollen upper lip 15 minutes after receiving COVID-19 vaccine |
| 53 | 2021-01-31 | lacrimation increased |
Extreme chills fevers Sneezing Runny nose watery eyes Fatigue Body aches . Extreme chills And fatigu...
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Extreme chills fevers Sneezing Runny nose watery eyes Fatigue Body aches . Extreme chills And fatigue started 34 hours after shot . Sneezing started 48 hours after the shot Runny nose watery eyes And body aches Started 56 hours .
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| 53 | 2021-01-31 | thirst |
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa...
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not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
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| 53 | 2021-02-01 | mouth discomfort, lip swelling |
Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad...
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Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
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| 53 | 2021-02-01 | pain in jaw |
Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Seve...
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Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
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| 53 | 2021-02-02 | ear itchiness |
23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patie...
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23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patient BP 98/62 RA, wnl per pt. P 77, RR 16, O2sat 95-97%. During evaluation pt stated felt slightly itchy throat and itching in her ears. Pt given Claritin 10 mg po at 12:19 pm and remained under observation by RN. Pt began feeling better, sipping water. P 88-91, RR 16, O2sat 98%. Reviewed pt status with MD. Pt allowed to leave at 12:35 pm.
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| 53 | 2021-02-02 | mouth numbness, mouth tingling |
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spont...
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Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-02 | visual impairment |
On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minute...
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On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minutes. When the vision was restored, I had a frontal headache.
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| 53 | 2021-02-02 | mouth tingling |
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che...
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Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
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| 53 | 2021-02-03 | mouth numbness |
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDE...
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DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
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| 53 | 2021-02-03 | eye pain, dry mouth, bloodshot eyes, sensitivity to light, eye swelling |
Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle...
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Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle pain; Fatigue; Increased dry mouth; GI upset; Nasal congestion; Wheezing; Shortness of breath; This is a spontaneous report from a contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262,), via an unspecified route of administration in left arm on 21Jan2021 at 16:45 as a single dose, for COVID-19 vaccination. The most recent COVID-19 vaccine was administered at a Workplace clinic. Medical history included rheumatoid arthritis dry eye, hypertension, anxiety and asthma. Concomitant medication included lisinopril (LISINOPRIL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), iron (IRON), oxymetazoline hydrochloride (CLARITIN ALLERGIC), montelukast sodium (SINGULAIR). No other vaccines were given within 4 weeks. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number:PFR-20364-01; in the right arm on 29Dec2020, at 09:00. On 22Jan2021 at 05:00, the patient woke the day after at 5AM with piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath. No treatment was received given for the events. The clinical outcome of piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath was recovering. Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products:no Vaccine Facility information available. Ethnicity information is available. Race information is available.
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| 53 | 2021-02-04 | eye twitching |
1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple o...
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1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue, 1/18 First Covid Test 1 Negative Continued symptoms 1/21 Went to PCP Covid rapid and Covid lab both negative Labs drawn all within normal limits Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
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| 53 | 2021-02-04 | taste impairment |
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate...
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Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
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| 53 | 2021-02-04 | lip itchiness, tongue itchiness |
Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips...
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Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips and tongue DAY 1 and DAY 5 Bilateral Hip and Knee pain DAYS 1 and DAYS 3-5 Flank Pain DAYS 3-5
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| 53 | 2021-02-07 | ringing in ears, ear pain, pain in jaw |
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va...
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Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
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| 53 | 2021-02-07 | lip swelling, eye itchiness, eye swelling |
SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 ...
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SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 AND BECAME WORSE LATER THAT MORNING. EXTREME TIREDNESS. TOOK BENADRYL TO RELIEVE THE ITCHING AND SWELLING.
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| 53 | 2021-02-08 | dry throat |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-09 | ringing in ears | Tinnitus beginning one day (1/20) after administration of second dose of COVID-19 vaccine. |
| 53 | 2021-02-10 | taste impairment |
After 30 minutes receiving the 1st dose of covid-19 vaccine, patient reported metallic taste. The h...
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After 30 minutes receiving the 1st dose of covid-19 vaccine, patient reported metallic taste. The heart rate was 83 bpm. The blood pressure was fluctuate from 125 to 150 / 70 to 83. After 15 minutes taking 2 tablets of Benadryl 25 mg, the metallic taste went away. Patient was back to work as usual.
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| 53 | 2021-02-11 | feeling of choking, mouth tingling | throat and tongue tingling, HA |
| 53 | 2021-02-14 | mouth tingling |
Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was giv...
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Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was given Benadryl 50mg IM. Within 15 seconds she reported not feeling well. Then she started seizing for about 30 seconds. Initial BP 148/88 and pulse ox 98. After 5 mins BP of 125/77 and pulse ox 99%. Patient regained consciousness, was A&O x3 but felt weak/tired. She was transported to the hospital.
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| 53 | 2021-02-14 | dry mouth, dry eye |
Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was havi...
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Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was having a flare up of sjogrens. Dry mouth and dry eyes were worse. Dry cough, chest discomfort was the most difficult to deal with and GERD issues got worse
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| 53 | 2021-02-14 | mouth tingling |
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak...
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Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
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| 53 | 2021-02-16 | mouth numbness, mouth tingling |
Numbness and tingling around mouth. Benadryl 25mg given at 1054am v/s at 1058am 145/82 p 74 r18 96%...
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Numbness and tingling around mouth. Benadryl 25mg given at 1054am v/s at 1058am 145/82 p 74 r18 96% v/s 131/71 68 16 97% numbness and tingling resolved at 1122am
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| 53 | 2021-02-18 | thirst |
7 days of serious nausea and severe heartburn Unable to eat or drink until day 7 Still have heartbu...
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7 days of serious nausea and severe heartburn Unable to eat or drink until day 7 Still have heartburn on day 7
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| 53 | 2021-02-22 | visual impairment, eye irritation | Foggy vision and irritation in the eye for 5 hours. |
| 53 | 2021-02-23 | mouth tingling, dry mouth | Patient complained of flushing, tingling tongue, dry mouth. |
| 53 | 2021-02-24 | thirst |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-26 | pain in jaw |
Numbing on left side of the face, unable to close left eye all the way no control on left side of th...
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Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
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| 53 | 2021-02-27 | eye swelling | Left eye very swollen |
| 53 | 2021-02-27 | tongue disorder |
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk...
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Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
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| 53 | 2021-02-28 | mouth tingling, feeling of choking, mouth numbness |
Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes...
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Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes when she alerted staff that she was feeling numbness and tingling to lips that was moving up face and down to throat. Pt stated that she also had slight difficulty breathing which was relived when she took off her mask. She stated that she has allergies to papaya and cantaloupe and this reaction was similar. Pt was given 50mg Benadryl and stated that she was feeling much better about 15 minutes later. Vital signs WNL. Pt d/c home with instructions on when to seek medical care.
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| 53 | 2021-02-28 | eye swelling |
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in...
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Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-03-01 | mouth tingling |
Patient reported feeling tingling in the tongue and around her mouth for approximately three hours a...
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Patient reported feeling tingling in the tongue and around her mouth for approximately three hours after receiving the COVID vaccine then subsided without any further intervention.
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| 53 | 2021-03-01 | ringing in ears | Significant ringing in the ears |
| 53 | 2021-03-02 | eye pain | Body aches, fatigue, mild headache, eyes hurt. Feel feverish but have no fever |
| 53 | 2021-03-03 | double vision |
I started to feel severe lethargy and fatigue. My eyes flared, double vision up with my usual autoim...
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I started to feel severe lethargy and fatigue. My eyes flared, double vision up with my usual autoimmune attack. I could not get out of bed for five days. Chills and back pain, joint swelling. It felt like a really flare up of my autoimmune condition. I also had similar problems with the first dose but not as bad. I was midway between my bi-weekly Cosentyx.
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| 53 | 2021-03-04 | oropharyngeal discomfort |
Within a few minutes of getting the injection my face began tingling. A few minutes after that the ...
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Within a few minutes of getting the injection my face began tingling. A few minutes after that the tingling turned into a burning feeling. My cheeks were slightly flushed but felt like I had a bad sunburn. At the same time my throat felt thick. I could talk and breathe but it definitely felt like it had swelled inside my throat. I also felt shaky. My hands were not shaky but I felt shaky on the inside. I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning. Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
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| 53 | 2021-03-06 | eye swelling |
Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted ...
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Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted for 4 hours. Both hands also were numb even longer. EMT's on site checked my vital signs. My blood pressure and oxygen were OK so they said I could drive home when I felt ready.
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| 53 | 2021-03-07 | lip swelling |
Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling...
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Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling faint. This happened 10 minutes after shot was given. Benadryl shot was given in arm and didn't help and then epipen was administered. Then taken to ER and given Decadron and Pepcid. Was monitored for 4 hours and sent home.
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| 53 | 2021-03-08 | mouth tingling |
Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively wors...
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Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and then intubated and had epi infusion.
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| 53 | 2021-03-08 | ear discomfort |
My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. ...
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My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. My mind was very foggy; I could not think clearly. It was hard to concentrate and focus. It felt like I was extremely groggy but not sleepy. My think pattern was very slow. My appetite decreased; I felt nauseous a couple of times. No fever. I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours. The longer the day went, the more severe the symptoms become. I took another 2 Tylenol tablets at bedtime, and went to bed earlier. During the day I drank lots of fluids, and ate light food.
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| 53 | 2021-03-08 | lip swelling, mouth numbness, eye swelling, eye pain |
Received vaccine on 3/4. Noticed swelling under right on 3/5 in the afternoon. Minimal under left...
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Received vaccine on 3/4. Noticed swelling under right on 3/5 in the afternoon. Minimal under left eye. Right eye more painful. On Monday 3/8 noticed swelling to right side of upper lip lasting through Tuesday 3/9. Described as painful, numb, and tingling. Stated she felt short of breath until morning of 3/9 with chills. At time of report right upper lip swollen but pt. says has decreased. Took Zyrtec, and Advil for relief. Pt. received fillers for under both eyes and lip on June 6, 2020. Swelling occurred where injection of filler was placed.
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| 53 | 2021-03-08 | swollen tongue, mouth tingling |
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protoc...
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Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
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| 53 | 2021-03-08 | thirst |
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hou...
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Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
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| 53 | 2021-03-09 | ringing in ears | Left ear buzzing followed by dizziness , headaches |
| 53 | 2021-03-10 | eye swelling |
My eye started swelling 48 hours after event. Continues to swell until closed. Saw an NP on 3.09.21 ...
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My eye started swelling 48 hours after event. Continues to swell until closed. Saw an NP on 3.09.21 - suggested Benedryl and cold compresses.
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| 53 | 2021-03-10 | mouth tingling | feels flushed, lips tingling, reports feeling throat closing. Evaluated by EMS-Cleared |
| 53 | 2021-03-10 | mouth tingling | tingling month and tongue. Evaluated by EMS-Cleared |
| 53 | 2021-03-12 | lacrimation increased |
Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye ...
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Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye lid only. No puffiness, slightly sore to the touch, eye is a bit watery, vision is currently unaffected.
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| 53 | 2021-03-14 | thirst, oropharyngeal discomfort |
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like s...
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Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side, Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
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| 53 | 2021-03-14 | mouth tingling |
Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day...
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Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day symptoms of body aches/joint pain, severe headache, neck back pain, fever 101. Heart palpitations.
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| 53 | 2021-03-14 | eye swelling |
Patient states she developed left eye swelling on the morning of 03/15/21. States she does not thin...
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Patient states she developed left eye swelling on the morning of 03/15/21. States she does not think its allergies since she took a claritin and it did not help her.
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| 53 | 2021-03-14 | vision blurred |
Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment ...
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Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours. Very distracting although not severe. Prevented sleeping. Took 1x advil 200mg. Resolved. Foggy head within 4 hours. Trouble focusing eyes and thoughts while having a conversation with neighbor. Resolved at 48 hours. Tiredness within 6 hours. Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours. Resolved.
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| 53 | 2021-03-15 | mouth tingling |
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in ...
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Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
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| 53 | 2021-03-15 | eye itchiness |
Client was vaccinated with her second dose of Pfizer @1030 and while waiting the recommended observa...
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Client was vaccinated with her second dose of Pfizer @1030 and while waiting the recommended observation time, she felt her eyes itching @1045. Client continued to self monitor as she has HX of these exact symptoms to other triggers and the notified medical staff @1130. No s/sx resp distress, no SOB, Client took 25mg of Benadryl in which she brought herself and felt her symptom diminish by 1200. Client advised by paramedic and nurse to seek further medical evaluation if symptom re-occurs.
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| 53 | 2021-03-15 | swollen tongue, dry mouth, dry throat |
Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood ...
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Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood pressure Dry mouth and throat Dizziness
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| 53 | 2021-03-15 | thirst, taste impairment, dry mouth |
Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, heada...
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Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, headaches, using albuterol inhaler in the morning for shortness of breath, bad taste in the mouth and stomach described as the taste of burnt rubber and smell and taste of ignited /lit matches, excessive thirst and dry mouth that has prevented me doing normal activities ~ general malaise and feeling unwell
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| 53 | 2021-03-15 | mouth tingling |
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w...
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Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
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| 53 | 2021-03-16 | loss of taste, loss of smell |
Received 1st dose of Pfizer COVID vaccine on 1/6/2021. On 1/11/2021 developed body aches, loss of ...
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Received 1st dose of Pfizer COVID vaccine on 1/6/2021. On 1/11/2021 developed body aches, loss of taste/smell, rhinorrhea, and pharyngitis. Positive COVID test.
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| 53 | 2021-03-16 | vision blurred |
nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on ...
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nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening. My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
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| 53 | 2021-03-17 | eye itchiness, swelling of eyelid, feeling of choking |
About four hours after receiving dose 2 of pfizer vaccine, I began sneezing, had a tickle in my thro...
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About four hours after receiving dose 2 of pfizer vaccine, I began sneezing, had a tickle in my throat and terribly itchy eyes. Then my eyes and throat swelled up so much that I couldn't open my right eye.
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| 53 | 2021-03-17 | taste impairment |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-17 | eye pain, eye swelling, vision blurred |
My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face a...
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My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face and neck itchy.
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| 53 | 2021-03-17 | mouth tingling, mouth numbness |
Patient complained of numbness/tingling to lips after receiving vaccine. Was monitored for 30 minute...
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Patient complained of numbness/tingling to lips after receiving vaccine. Was monitored for 30 minutes by provider and symptoms resolved.
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| 53 | 2021-03-18 | eye pain |
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute...
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received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
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| 53 | 2021-03-20 | taste impairment |
At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was d...
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At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was driving home and continued for an hour or 2 after shot. For about 24 hours, I had very intermittent cramping. For a couple of hours after shot, I had a metallic taste in my mouth. I also had some stiffness in my right hand and wrist appear after a few hours that was gone when I woke up the next day. I had 1 episode of loose stools the next morning. For 5 days after I felt off especially in the morning, with some slight dizziness, and something similar to restless leg syndrome which I have had some years ago. (at night.) I took my blood pressure and it was low. It remained low in the morning for 5 days.
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| 53 | 2021-03-20 | eye pain |
Head ache, muscle aches, eyes were aching, chills, sweats, exhausted, tired, low grade temperature 1...
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Head ache, muscle aches, eyes were aching, chills, sweats, exhausted, tired, low grade temperature 100.4
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| 53 | 2021-03-21 | dry eye, dry mouth |
1/9/21 after 2nd dose on 1/7/21 I had a moderately severe headache and severe fatigue. By 1/10/21 A...
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1/9/21 after 2nd dose on 1/7/21 I had a moderately severe headache and severe fatigue. By 1/10/21 AM I was fine. 3/1/21 I developed moderately severe dry mouth and dry eyes that haven't resolved.
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| 53 | 2021-03-21 | thirst |
Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Inj...
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Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
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| 53 | 2021-03-21 | dry eye |
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ...
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Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
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| 53 | 2021-03-22 | ear pain |
Extreme headache; pain in both ears; fever; chills; nausea; This is a spontaneous report from a cont...
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Extreme headache; pain in both ears; fever; chills; nausea; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included psoriasis. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 26Jan2021 at 16:00 in the right arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified low dose blood pressure medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 at 07:00, the patient experienced extreme headache, pain in both ears, fever, chills and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events headache, pain in both ears, fever, chills and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 53 | 2021-03-22 | swollen tongue |
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT...
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FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
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| 53 | 2021-03-22 | loss of taste, loss of smell |
Patient vaccinated 1/3/2021. On 1/11/2021 developed headache, chills, cough, aches, nausea, loss of...
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Patient vaccinated 1/3/2021. On 1/11/2021 developed headache, chills, cough, aches, nausea, loss of taste/smell, and rhinorrhea. Tested positive for COVID.
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| 53 | 2021-03-23 | eye pain, eye discomfort |
Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sens...
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Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sensitivity, orbit pain, right temple pain, pain at base of skull, forehead pain & sensitivity. right eye discomfort
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| 53 | 2021-03-23 | mouth tingling, mouth numbness | facial and tongue numbness with tingling |
| 53 | 2021-03-24 | mouth tingling |
15 min after shot tingling of upper lip and tongue. similar to symptoms with iodine allergy. ems cal...
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15 min after shot tingling of upper lip and tongue. similar to symptoms with iodine allergy. ems called
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| 53 | 2021-03-24 | mouth tingling, mouth itchiness |
Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored fo...
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Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored for 30 minutes. She alerted staff after approx 25 min that she was feeling unwell. Reported that she developed generalized headache, ear fullness and tingling in the upper lip soon after receiving vaccine. Denied symptoms of anaphylaxis. She was brought into the triage area. She appeared well, in no distress, no evidence of angioedema or hives. VS were taken: BP 114/70, HR 87 bpm, SpO2 97%. She was given zyrtec 10 mg PO once. After approx 10 minutes she reported that she was experiencing new mild itching in the roof of her mouth and back of throat. She was then given benadryl 25 mg PO once. VS taken again: BP 112/74, HR 86 BPM, SpO2 98%. Continued to appear well. There was no observed difficulty breathing. No hives or evidence of angioedema. After approx 10-15 minutes she reported significant improvement of symptoms. She reported resolution of headache, ear fullness, tingling of the upper lip, and 90% resolution of itching of roof of mouth and back of throat. She denied feelings of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness. She was monitored for an additional 30 minutes after reporting feeling improved. During that time she reported resolution of symptoms. She continued to appear well. Prior to leaving she was counseled that should she develop any recurrent tingling in the lip, itching in the throat/mouth, feeling of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness she should seek urgent medical attention. Her daughter is waiting outside and will escort her home. Encouraged her to call with questions or concerns. She verbalized understanding of and agreement with plan
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| 53 | 2021-03-24 | feeling of choking, mouth numbness |
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ...
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Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
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| 53 | 2021-03-24 | mouth numbness |
staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in th...
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staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in the past and she stated NO but was nauseated and felt funky from the flu shot. covid vaccine given at 1523 and approx. 3 -4 minutes after in the observation area she started stating that she felt numbness in her mouth and felt funky. she also was a little tachy and shaky of her upper extremities. we followed standard protocol for infusion reaction and gave 1 dose of epinephrine stat and activated emergency response system. she started to feel better but was nauseous. EMS arrived and no other doses of epinephrine administered. EMS transferred to ER.
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| 53 | 2021-03-25 | vision blurred, bloodshot eyes |
Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision ...
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Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision blurred and the store darkened and felt like it was closing in. I felt dizzy and nausea. I sat down away from people and let someone know. I got a pink in my eyes and some parts of my body. I waited about 45 minutes and my vision cleared and the dizziness faded considerably. The nausea remained and some pinkness remained. Slight headache off and on for two days. Had minor discomfort for two days.
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| 53 | 2021-03-25 | mouth numbness, swollen tongue |
Pt complained numbness/swelling in tongue. I gave her 2 diphenhydramine 25 mg immediately. Observed...
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Pt complained numbness/swelling in tongue. I gave her 2 diphenhydramine 25 mg immediately. Observed her for total of up to 24 minutes. All this time she was not having and chocking/closing of throat. She could talk fine and awake and alert, pt's husband was with her. I called her PCP and informed them about having this reaction and got EpiPen RX for her and dispensed her to take it home. I walked through with her on how to use it and instructed to call 911 if any emergency situation and any time she feels she cant breath. She was in the pharmacy under observation for about an hour and then she left with her husband with EpiPen to go home. I called her again around 4:30 pm to check on her. She was feeling ok
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| 53 | 2021-03-25 | mouth tingling, feeling of choking, swollen tongue |
Shortly after vaccination. Patient complained of tingling in mouth, throat and lips, and tongue swe...
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Shortly after vaccination. Patient complained of tingling in mouth, throat and lips, and tongue swelling. Patient was evaluated by EMS. IM Benadryl and nebulizer given by EMS. Patient was transported by EMS to Emergency Room for further assessment.
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| 53 | 2021-03-25 | ringing in ears | Tinnitus |
| 53 | 2021-03-26 | eye swelling |
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ...
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03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
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| 53 | 2021-03-26 | ear pain |
Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain i...
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Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain in inner ears. Most severe symptoms persisted for 2 days and began to subside on day 3. Fatigue remained for an additional 2 days for a total of 5 days.
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| 53 | 2021-03-26 | eye swelling, bloodshot eyes |
Left eye swollen and very red in morning. Left side of neck very stiff and painful Injection was i...
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Left eye swollen and very red in morning. Left side of neck very stiff and painful Injection was in left arm
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| 53 | 2021-03-26 | dry mouth, thirst | Sore arms, extreme fatigue, hunger, dry mouth/thirst. Symptoms persisted for about 2 to 3 days. |
| 53 | 2021-04-08 | visual impairment |
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com...
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site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
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| 53 | 2021-04-12 | double vision |
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/...
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Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
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| 53 | 2021-04-17 | ringing in ears |
unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing he...
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unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing her irritation; Tinnitus like symptoms; mild headache; mild sinus irritation; This is a spontaneous report received from a contactable consumer(patient). A 53-year-old female patient(not pregnant) received BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 02:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medication included estradiol, progesterone (BIJUVA) taken for hormone replacement therapy. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 15:00, She experienced tinnitus like symptoms, unusual sensation of sharp tinny sound when she was talking. First time was in a restaurant and she could hear someone talking nonstop causing her irritation and onset of a mild headache. She was also feeling mild sinus irritation. There was no treatment. Outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 53 | 2021-04-18 | eye movement disorder, double vision |
At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximat...
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At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximately 5-8 minutes. I checked my blood pressure, which was 158/89. After about 10 minutes, my vision returned to normal. I immediately went to the emergency department and was admitted. I was diagnosed with a TIA.
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| 53 | 2021-04-24 | dry mouth |
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout...
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Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
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| 53 | 2021-04-24 | smell distorsion, taste disorder |
diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of ...
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diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of her sense of smell since Mar2020, it came back really strong; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 31Mar2021 16:00 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diverticulitis, abscess in back at the moment of the vaccination, and losing part of her sense of smell from Mar2020. There were no concomitant medications, and vaccines in four weeks. The patient experienced dizziness, nausea and generally unwell. Two days after receiving the vaccine, on 02Apr2021 15:00, patient was in the ER with diverticulitis. She had to take Ciprofloxacin and metronidazole. After losing part of her sense of smell since Mar2020, it came back really strong. It affected her sense of taste and all food taste bad now. It was like pregnancy sickness. Her sense of smell came in an estrange manner. The events were experienced on 02Apr2021 15:00. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
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| 53 | 2021-04-26 | swollen tongue |
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her...
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This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
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| 53 | 2021-04-28 | loss of smell, loss of taste |
Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrh...
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Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrhea that eventually led to dehydration and finally colitis that resulted in ER visit for fluids; sent home; next day, passed out at home, back to ER and was admitted for the colitis.
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| 53 | 2021-05-03 | deafness unilateral |
Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient)...
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Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (Lot Number: EN6198) at a single dose, and the second dose via an unspecified route of administration in left arm on 19Mar2021 13:30 (Lot Number: EN6199) at a single dose for covid-19 immunization at the age of 53 years old. Medical history included hypertension and known allergies to sulfa, both from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included irbesartan taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden hearing loss in right ear on 10Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, and cased disability or permanent damage. The patient underwent lab tests and procedures which included covid-19 virus test (nasal swab): negative on 14Apr2021. Therapeutic measures were taken as a result of sudden hearing loss in right ear included steroid injection series into eardrum. The outcome of the event was not recovered.
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| 53 | 2021-05-07 | blindness |
Loss of vision in left eye.; This is a spontaneous report from a contactable consumer. A 53-year-ol...
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Loss of vision in left eye.; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in right arm on 13Apr2021, at 10:00 as single dose for covid-19 immunisation. Medical history included Lupus, Hashimotos, chronic obstructive pulmonary disease, asthma, non- alcoholic fatty liver disease, and allergy from unknown dates. The patient experienced loss of vision in left eye on 13Apr2021, at 10:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent other tests and magnetic resonance imaging in Apr2021 with unknown results. Therapeutic measures were taken as result of the event. No COVID prior to vaccination was noted. No COVID test was performed post vaccination. The outcome of loss of vision in left eye was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 54 | 2020-12-31 | thirst | Fevers, muscle, joint aches, fatigue, "crawling skin"extreme thirst X6 days as of this form |
| 54 | 2021-01-02 | mouth tingling |
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a...
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Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
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| 54 | 2021-01-03 | eye swelling |
48 hours later bilateral eyes swollen. Saw dr. in office and treated with steroid cream and allergy...
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48 hours later bilateral eyes swollen. Saw dr. in office and treated with steroid cream and allergy meds resolved without difficulties
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| 54 | 2021-01-04 | swelling of eyelid, lip swelling |
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ...
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About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
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| 54 | 2021-01-04 | eye itchiness |
Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl ...
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Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.
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| 54 | 2021-01-04 | bloodshot eyes |
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sp...
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Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
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| 54 | 2021-01-05 | lip swelling |
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel...
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20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
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| 54 | 2021-01-05 | taste disorder |
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he...
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About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
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| 54 | 2021-01-05 | visual impairment |
One week after the vaccine I was find until....I got out of my car after driving and started stagger...
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One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
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| 54 | 2021-01-05 | loss of smell, loss of taste |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
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| 54 | 2021-01-06 | mouth tingling |
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took ...
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Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
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| 54 | 2021-01-06 | mouth numbness |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-07 | pain in jaw, mouth pain |
COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain s...
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COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain since Sunday 1/3/20 worse in the morning,. patient describes it as a dullness on the left side of face. Denies any trauma to area. No hx of TMJ. Denies any facial droop, or dry eye, no weakness. She tried NSAIDs with no improvement, however pain with opening her mouth.
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| 54 | 2021-01-07 | eye irritation | Warm neck and face. Burning sensation in eyes. |
| 54 | 2021-01-10 | vision blurred |
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, pa...
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Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.
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| 54 | 2021-01-10 | oropharyngeal discomfort |
Patient complained of dizziness and feeling of something in her throat. She felt the need to clear h...
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Patient complained of dizziness and feeling of something in her throat. She felt the need to clear her throat.
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| 54 | 2021-01-10 | pain in jaw |
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri...
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Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
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| 54 | 2021-01-11 | swelling around the eyes |
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma an...
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pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine
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| 54 | 2021-01-12 | inability to speak |
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was ...
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I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU & COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
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| 54 | 2021-01-12 | swelling around the eyes |
Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED. She had some mi...
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Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED. She had some mild asthma symptoms earlier in the day (before vaccination) and these did not worsen after the vaccination. She did not have throat tightness, chest pain, dizziness, rash, itching. She has hx asthma, GERD. She has allergy to sulfa and cipro (Rash) and Prozac (psychosis). In ED, patient was given IV benadryl and famotidine and discharged with Rx methylprednisolone and epipen.
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| 54 | 2021-01-13 | taste impairment |
Metallic taste for about 1 1/2 hrs immediately following the injection. It did go away.; This is a ...
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Metallic taste for about 1 1/2 hrs immediately following the injection. It did go away.; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on her left arm on 31Dec2020 at 10:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food and other products; all unspecified. Prior to vaccination, the patient was not diagnosed with COVID-19. No vaccines received within 4 weeks prior to COVID vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID) which was received within 2 weeks of vaccination. The patient experienced metallic taste for about 1 1/2 hrs (hours) immediately following the injection on 31Dec2020 at 10:45. It did go away. The patient did not receive treatment for the adverse event. Outcome of the event was recovered on unspecified date.
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| 54 | 2021-01-13 | loss of taste | TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED |
| 54 | 2021-01-14 | eye swelling |
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,...
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1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
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| 54 | 2021-01-14 | eye pain, bloodshot eyes |
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea....
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Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
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| 54 | 2021-01-14 | taste impairment, eye bleeding |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | eye bleeding, taste impairment |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-14 | eye twitching |
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as...
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Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
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| 54 | 2021-01-14 | vision blurred |
convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints wer...
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convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
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| 54 | 2021-01-15 | mouth tingling |
At approximately 20 min following dose administration noted left neck pain subsequently developed pe...
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At approximately 20 min following dose administration noted left neck pain subsequently developed perioral paresthesia, chest tightness. No stridor, drooling, wheezing or nausea/vomiting. Vitals were stable. Patient states that she took Claritin prior to her vaccination. No medications since symptoms started. States symptoms have improved in all told lasted approximately 30 min.
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| 54 | 2021-01-19 | dry throat |
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of b...
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Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
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| 54 | 2021-01-20 | mouth tingling, feeling of choking |
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie...
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Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
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| 54 | 2021-01-21 | oropharyngeal discomfort, mouth numbness |
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ...
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It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
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| 54 | 2021-01-21 | taste impairment |
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s...
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Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-21 | mouth tingling, pain in jaw |
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk...
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Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
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| 54 | 2021-01-24 | mouth numbness, mouth tingling |
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ...
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Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
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| 54 | 2021-01-25 | vision blurred | Reported tightness in throat, headache, fever,body aches, and blurry vision. |
| 54 | 2021-01-25 | tongue disorder | Within 3 minutes of receiving the vaccine, felt that tongue was "getting fat" |
| 54 | 2021-01-26 | dry throat, tongue disorder | "THICK TONGUE"/"THROAT DRY" INCREASED PULSE 90-100 BPM |
| 54 | 2021-01-27 | vision blurred |
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable ...
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Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
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| 54 | 2021-01-27 | lip swelling |
Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to...
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Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to work. Was placed on 3 days of prednisone to decrease the swelling. Prednisone did decrease the swelling. Spoke with my primary doctor on the phone as it was after hours by the time I called him who prescribed the prednisone.
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| 54 | 2021-01-27 | loss of taste, loss of smell |
losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous repo...
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losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous report from a contactable pharmacist. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on her left arm on 19Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The reaction with the first dose was losing taste and smell for two days (unknown date). The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
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| 54 | 2021-01-29 | mouth tingling |
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing...
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20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
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| 54 | 2021-01-31 | visual impairment |
I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with...
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I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with my RIGHT eye. I had a sore left arm and headache, which I attributed to the vaccine. By 12/27/20, I called the emergency number at my primary ophthalmologist as was seen. They thought I had a posterior vitreous detachment and asked me to see my primary eye doctor in a week. By 12/30/20 I could not see to work and called the eye doctor and they decided I should see my retinal specialist who deals with problems with my left eye. He could see nothing to explain my decreased acuity and told me to keep my follow up at the other office. I saw a Dr on 1/4/21, who takes care of my left eye cataract and glaucoma. He called in an associate. My vision had further declined and they thought I had ocular neuritis. I couldn't see the big E on the eye chart at all at my worst. I was scheduled for an MRI of the head, which showed ocular neuritis in my right eye. Dr assumed care and I started IV steroids on 1/13 for 3 days, followed by oral prednisone taper. I also was referred to a neurologist to rule out MS. I saw Dr. 1/28/21. After the steroids, my vision improved, but I still can't work or drive. Neurologist does not think I have MS and is ruling out NMO but doesn't think I have that either.
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| 54 | 2021-01-31 | dry throat |
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ...
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body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
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| 54 | 2021-02-01 | taste impairment, mouth tingling |
Metallic taste in mouth started approximately 1 hour after receiving vaccine and still reporting met...
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Metallic taste in mouth started approximately 1 hour after receiving vaccine and still reporting metallic taste. Tingling on tongue started after receiving vaccine and went away after a few days.
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| 54 | 2021-02-01 | ringing in ears |
Tinnitus; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-...
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Tinnitus; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=PFZ39), via an unspecified route of administration in left arm on 14Jan2021 19:00 at first single dose for covid-19 immunisation. Medical history included obesity, depression, hypothyroidism. Other medications the patient received within 2 weeks of vaccination included: levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took demerol and experienced drug hypersensitivity. The patient experienced tinnitus on 14Jan2021 20:00 with outcome of not recovered. Since about an hour after receiving the vaccine, the patient's ears had been ringing. She had never experienced this before. It's noticeable but did not interfere with daily activities. Event was considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-02-02 | visual impairment |
Impaired right eye vision. 01/29/2021- Retina Specialist diagnosed: Hemiretinal Vein Occlusion Rig...
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Impaired right eye vision. 01/29/2021- Retina Specialist diagnosed: Hemiretinal Vein Occlusion Right Eye. Will begin treatment for ocular injections in the next week
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| 54 | 2021-02-02 | lip swelling |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-03 | mouth tingling |
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i...
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10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
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| 54 | 2021-02-03 | smell distorsion |
Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) ...
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Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 22Jan2021 12:15 at single dose for COVID-19 immunisation. Medical history included elevated blood pressure and allergy to raw walnuts and pecans. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included biotin (BIOTIN), vitamin d nos (VITAMIN D NOS), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), fexofenadine, hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), cetirizine. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 15:00, the patient experienced typical headaches, muscle aches, nausea, distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine. No treatment was received for the adverse events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 54 | 2021-02-04 | mouth tingling, dry mouth, feeling of choking, mouth numbness |
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ...
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PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
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| 54 | 2021-02-05 | eye pain, pain in jaw |
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy ...
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High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
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| 54 | 2021-02-05 | feeling of choking |
Rec'd Vaccine and at 2:38 associate C/O burning/tingling in throat. Advised to take Benadryl but dec...
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Rec'd Vaccine and at 2:38 associate C/O burning/tingling in throat. Advised to take Benadryl but declined.
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| 54 | 2021-02-05 | lip swelling |
Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly a...
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Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly achy so I took my temp and it read 100.6. I ate a piece of toast and took one 500 mg tablet of a Tylenol and went to work but was sent home due to the fever after getting home my aches kept getting worse I developed a headache and my temp fluctuated all day between 99 3 and got as high as 101.7 bye the afternoon. When I went to bed around 10 p.m. my temp had dropped to 99 but my upper lip felt puffy and was slightly swollen. When I got up the next morning at approximately 6 a.m. my upper lip was still swollen and my right cheekbone very was very tender to the touch. Upon submitting this report it is approximately 1:15 Eastern Standard Time and my lips are mostly back to normal but around my mouth is very tender and to my right cheek bone is still very tender to the touch. Other than that headaches are gone fever is gone and I overall feel pretty good.
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| 54 | 2021-02-06 | mouth numbness | Numbness of lips, mouth, chin, upper area of neck |
| 54 | 2021-02-07 | pain in jaw |
both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles ...
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both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles so tight that I was unable to walk/ just a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body); like a spasm; bilateral jaw pain; slight numbness on by left face; face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw; redness on my left cheek; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 21Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included shellfish allergy. Concomitant medications included received within 2 weeks of vaccination but were not reported. The patient previously took codeine and experienced allergy. On 21Jan2021 11:30, both of her legs seized. The muscles so tight that she was unable to walk (like a spasm). There was no twitch just a muscular contraction that left her unable to walk properly (the left side seem to be the tightest side of by body). The patient also had bilateral jaw pain (not sure if it was because she was in so much pain in the legs that she was clenching my teeth). She also had slight numbness on by left face and by the evening she had redness on her left cheek but it went away. Her face still had a bit of muscle sensitivity (tingling sensation) near the mouth and jaw. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-02-09 | mouth numbness |
Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatmen...
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Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatment: Benadryl Outcome: Recovered in 2 hours
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| 54 | 2021-02-09 | tongue itchiness, taste impairment |
Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis an...
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Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis and shortness of breath. On VS Heart rate and blood pressure were elevated O2 sat was WNL. Patient w as placed in a supine position and VS were repeated after 15 min and she felt better and VS were now WNL
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| 54 | 2021-02-15 | mouth tingling |
c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were...
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c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were within normal limits. Alert and oriented. Given IM benadryl and Epi. Transported to ED.
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| 54 | 2021-02-17 | ringing in ears |
Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous rep...
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Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered "Big echo on right ear" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported "related".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2; the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-21 | mouth numbness |
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Mov...
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Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
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| 54 | 2021-02-22 | swollen tongue, mouth tingling |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | eye swelling |
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied dif...
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Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
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| 54 | 2021-02-22 | tongue discomfort, mouth discomfort |
burning tonge, oral mucosa burning few hours after vaccine dose #1, much milder after vaccine dose ...
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burning tonge, oral mucosa burning few hours after vaccine dose #1, much milder after vaccine dose #2
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| 54 | 2021-02-24 | gaze palsy |
COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea...
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COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea, headache, fatigue, and chills following vaccination. On Monday 1/11/21, pt woke up to a large, red, discolored, warm, grapefruit-sized lump on her arm at site of injection. PA at clinic she worked with was curbsided, who said it might be cellulitis. Pt called her PCP who issued prescription for cephalexin 500 mg cap PO TID x 10 days on 1/11/2021. After 2 days of therapy, pt reports lump is still red, discolored, and grapefruit-sized, but is no longer warm. 2/2/21: Pt received 2nd dose of COVID vaccine without issue.
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| 54 | 2021-02-24 | visual impairment, dry mouth |
Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is ...
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Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is a 54 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience mouth dryness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes seasonal allergies (took zyrtec this am as routinely scheduled), htn, hld. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/19/21 1533 02/19/21 1536 02/19/21 1541 02/19/21 1600 BP: (!) 157/91 (!) 164/91 (!) 158/92 (!) 149/87 BP Location: Right arm Pulse: 88 SpO2: 99% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt stable and doing well. Pt agreeable to monitor symptoms. Aware of when to seek emergent care. Follow up with pcp otherwise. Pt given ride with one of her co-workers. Pt ambulatory out of the facility. Electronically Signed 2/19/2021 3:41 PM
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| 54 | 2021-02-25 | lacrimation increased |
Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes aft...
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Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes after the shot, the right side of my face felt numb and tingly (Felt like when novocaine is wearing off.) Continued for 48 hours and worsened with slight drooping when smiling. Clearing my throat a lot and my right eye keeps tearing up. The doctor confirmed it was "Bell's Palsy" this morning and I have been put on Prednisone.
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| 54 | 2021-02-26 | visual impairment, mouth numbness |
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis...
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Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
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| 54 | 2021-02-28 | mouth numbness |
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient complained of lip numbne...
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Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient complained of lip numbness. She was monitored by EMS. No further intervention.
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| 54 | 2021-02-28 | mouth tingling |
Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and i...
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Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment. Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm. By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
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| 54 | 2021-03-01 | eye itchiness, lip swelling |
Post vaccination and while in recovery experienced itchy eyes, proceeded by swelling of upper lip, i...
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Post vaccination and while in recovery experienced itchy eyes, proceeded by swelling of upper lip, itchy throat and coughing. Remained alert and oriented to person, place and time. Rapid Response Team called, vaccine recipient transported to Emergency Room. Release to home post recovery.
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| 54 | 2021-03-02 | ear swelling, swollen tongue |
Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally...
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Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally low 110/70 but went from 166/86 at 1333 HR 80 02 100%, then BP 163/88 at 1404 HR 74 02 100%, then at 1409 HR 68 BP 175/110 RR24 O2 100% 1405 - 911 called took benadryll at 1330 (25 mg) then again 1349 took 2nd dose of benadryll 25 mg liquid capsules. PT has adverse reactions to epinephrine. 1412 tongue swelling. by 330 pm patient went home prepared to go to ER if anything changed. She walked around in cool air and had hives move around her body. Not shot in upper right arm. It was tasted during injection. Then after the shot reactions kicked in at 20 minutes moving up the right side primarily same as shot side. Arms, chest, and face flush off and on. Swelling moved around.
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| 54 | 2021-03-02 | smell distorsion |
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells...
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Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
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| 54 | 2021-03-02 | swollen tongue |
her tongue swelled/started to have tongue swelling; This is a spontaneous report from a contactable ...
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her tongue swelled/started to have tongue swelling; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 54-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1203, expiration date: unknown), via an unspecified route of administration from 26Jan2021 to 26Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. Concomitant medications were not reported. On 26Jan2021, after the administration of the vaccine her tongue swelled and started to have tongue swelling. Therapeutic measures were taken as a result of her tongue swelled/started to have tongue swelling which included Benadryl. The outcome of the event was recovered on an unspecified date.
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| 54 | 2021-03-03 | mouth tingling, mouth numbness |
54 y.o. female a past medical history as documented below presenting to the ED for evaluation of pos...
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54 y.o. female a past medical history as documented below presenting to the ED for evaluation of possible allergic reaction. She received her 1st COVID-19 vaccine just prior to arrival. Seconds after receiving the vaccine she developed numbness/tingling to the roof of her mouth and her tongue and was advised to come to the ED for further evaluation. She denies swelling of the face, throat, lips or tongue, cough, shortness of breath or difficulty breathing. No headache, visual changes, weakness, extremity numbness/paresthesias. Symptoms improving upon arrival to the ED. Treated with PO diphenhydramine, observed ~ 2 hours and released without incident.
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| 54 | 2021-03-03 | mouth numbness |
The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and co...
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The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and continues to lessen as the day goes on. It is believed that my body may have just responded quickly. I was monitored for a few extra minutes, and then released.
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| 54 | 2021-03-03 | mouth numbness | lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared |
| 54 | 2021-03-04 | eye disorder, mouth tingling |
No adverse reactions other then pain in the injection site and being tired then last night 48 hours ...
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No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching. Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle. Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
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| 54 | 2021-03-05 | swollen tongue |
5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it ...
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5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it was difficult to swallow. She also reported feeling like her tongue was swelling mildly. She felt mild itching but denied rash, chest pain, or difficulty breathing. Also denied nausea, vomiting, abdominal pain. She received 50 mg of IM Benadryl and was observed until an ambulance arrived to transfer her to an emergency department. She felt better after the Benadryl. Reports a history of similar reaction to eating berries.
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| 54 | 2021-03-08 | ringing in ears | Chills, mild fever (99.5F) and very loud Tinnitus Fever only lasted 6 hours but tinnitus continues |
| 54 | 2021-03-08 | mouth numbness |
Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-...
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Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-treated with benadryl and symptoms resolved after about 2 hours.
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| 54 | 2021-03-09 | mouth numbness |
15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became nu...
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15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became numb. I administered benadryl 30 minutes after receiving the vaccine. The symptoms came and went throughout the next 4 hours. I administered a second dose of benadryl 4 hours after the vaccine and that seemed to reduce the symptoms greatly. My temperature was slightly elevated during this 4 hour period, as well. I took tylenol and that was effective. I had no further symptoms overnight or today. My concerns were about whether or not I should get second vaccine.
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| 54 | 2021-03-09 | mouth pain |
Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactab...
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Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactable consumer. This 54-year-old female consumer (patient) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 06Jan2021 as a single dose for COVID-19 immunization at a hospital. Relevant medical history included Hypertension, allergic rhinitis. Relevant concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), HCTZ, magnesium oxide (MAG OXIDE), multivitamins. The patient was not diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date in Jan2021 about a week after vaccine injection, the patient experienced brief, intermittent sharp pain on R side of mouth, lasted 2 days. The outcome of the event was recovered. The patient did not receive any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-03-09 | mouth tingling |
difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This...
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difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-03-10 | mouth tingling | Tachycardia, tingling in mouth, evaluated by medics, cleared. |
| 54 | 2021-03-10 | swollen tongue | scratchy throat and tongue. Tongue feels swollen |
| 54 | 2021-03-11 | mouth numbness |
Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time....
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Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time. The numbing continued down the right side of my right leg. I didn't think much of it because I thought it was the way I was sitting. I didn't report it to anybody at that time. I got in my car and my three right toes started to numb. Then I felt it down my arm and the right three fingers. About 15 minutes later my jaw muscle, then up to my temple and across the fatty area of the eyebrow went numb. Several minutes later I noticed my nostril and right side of my tongue numb. It felt like my tongue and face were swollen but when looking in the mirror they were not and there was no drooping when I smiled and raised my eyebrows. It was a similar feeling that I have had when a shot has almost worn off from a dental procedure. The feeling and the movement is there but still tingly. The arm, leg, and toe numbness went away 2-3 hours later on the same day of the shot. I had no numbness on the left side. Two days later I still have the same numbness on my right two fingers, tongue, jaw, eyebrow area, and nostril.
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| 54 | 2021-03-11 | tongue discomfort, taste impairment |
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning...
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At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
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| 54 | 2021-03-11 | eye irritation, eye itchiness |
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou...
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Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
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| 54 | 2021-03-11 | mouth tingling |
Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Bena...
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Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Benadryl and Inhaler. THursday patient still using Benadryl and used Prednisone. Saw MD Friday 3/12. Getting better now.
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| 54 | 2021-03-11 | mouth tingling | tingling in tongue and lips, rash on neck, certizine given 10mg |
| 54 | 2021-03-14 | swollen tongue, lip swelling |
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl...
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Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
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| 54 | 2021-03-14 | deafness, ear discomfort, ringing in ears |
On that day I woke up with hearing loss in my right ear, feeling of fullness and pulsatile tinnitus....
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On that day I woke up with hearing loss in my right ear, feeling of fullness and pulsatile tinnitus. I was seen by my Primary doctors office and given Amoxicillen for days with a Medrol dose pak. After 5 days this did not improve and was seen by ENT. Audiology testing was done and I was diagnosed with Sudden Sensorineural Hearing Loss of my right ear of moderate degree. MRI testing was done on 3/12/2021 and revealed no reason for these symptoms. Prednisone 30 mg was taken for 7 days tapering to 20 mg for 3 days and then to 10 mg for 3 days. Follow up is on April 6 to ENT. Hearing may not return and pulsatile tinnitus may remain.
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| 54 | 2021-03-14 | mouth tingling |
Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receivin...
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Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receiving vaccine. Pt has extensive medical hx and hx of severe allergic reactions, carries epi pen with her. Epi (given asap after start of symptoms) and Benadryl given here prior to transfer to ED- Medical Emergency Team immediately called at onset of symptoms and transferred to ER with them.
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| 54 | 2021-03-15 | mouth tingling |
My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I coul...
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My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I could take benadryl (which I brought with me). The person watching us texted someone and they came in and looked at me, asked me what was happening, took my blood pressure and said to take 2 benadryl. I told the nurse I only take one benedryl when this happens. She said take 2 benadryl. I did take 2 benadryl 12 minutes after my vaccine. My blood pressure went up. They called an ambulance and I went to the Hospital. My blood pressure was 176/105 at 11:50 am. While I was in the ER, I took a selfie and noticed that I had a rash. No one mentioned that earlier so I am guessing that is why they had me take 2 benadryl. At the ER I was put on an IV - NS .09% 1000ML at 12:27 pm. Then at 13:04 I was given Pepcid 40 MG/NS 250 ML IV at 500 ml/hr intravenous. At 1:12 pm my blood pressure was 138/96 and at 2:31 pm it was 135/70. My rash went away then. Up until last week I have been taking benadryl and/or pepcid everyday since the vaccine. I would still get a rash. I have not had the rash for about 5 days.
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| 54 | 2021-03-15 | pain in jaw |
slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tirednes...
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slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tiredness,
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| 54 | 2021-03-16 | mouth itchiness |
Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of fe...
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Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of feeling itchy and reddness at injection site, runny nose. No hives noted. 0754: 126/67, 98% O2, 77 HR 0805: 118/66, 98% O2, 75 HR; still c/o itchiness and redness at injection site, post-nasal drip 0820: Pt stated that she is feeling itchy in mouth and is having thicker post-nasal drip. Code Medic called and at bedside within a minute. Taken via wheelchair to ED and pt remained awake and alert. Patient reports previous anaphylactic reaction after receiving the flu shot. Discharged home from ED 1000
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| 54 | 2021-03-17 | mouth tingling |
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li...
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Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
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| 54 | 2021-03-17 | swollen tongue |
She got the Pfizer vaccine at the medical center at 2:15pm. and her tongue started swelling around...
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She got the Pfizer vaccine at the medical center at 2:15pm. and her tongue started swelling around 6pm. It got large enough that she felt that she may soon have difficulties swallowing. After the sides of her tongue started swelling , she took two Benadryl and the swelling gradually went down. Of note, she took two aspirin around 4:30pm and ate grapes and pumpkin seeds before the reaction. Denies shortness of breath, swelling of the lips or eyelids, rash, or any other symptoms.
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| 54 | 2021-03-17 | swollen tongue |
c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty ...
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c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report. No resp difficulty. Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85. 12:30pm Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction. All transport to closest ER.
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| 54 | 2021-03-18 | mouth pain |
Large boil/nose formed inside right roof of mouth very painful and full of puss. The dentist could ...
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Large boil/nose formed inside right roof of mouth very painful and full of puss. The dentist could only drain 1/2 of it. I do have pictures if needed.
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| 54 | 2021-03-19 | lip swelling, mouth tingling |
History of histamine poisoning related to tuna. She states she is aware when to go to the ER. Sympto...
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History of histamine poisoning related to tuna. She states she is aware when to go to the ER. Symptoms are lower lip swelling, tingling of mouth. Refuses transfer to hospital.
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| 54 | 2021-03-19 | mouth tingling |
Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt ...
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Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt like her reaction was more anxiety related.
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| 54 | 2021-03-20 | eye swelling |
At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a...
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At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a lot. She took a Claritin, then took a shower. In the shower, she began feeling itchy everywhere, especially in the face. She developed hives around the body (3-4 small patches on underarm, legs). There was also a hive patch on her left eyelid, which started as a small bump, but worsened while she was in the shower. It grew bigger, taking up half of her eyelid. She came out of the shower 10-15 minutes after she began sneezing. 20 minutes after that, her body hives subsided but the eye hive worsened further. The hive took up her entire left eyelid and the eye was swollen nearly shut. Before going to bed (9:30pm), she took a Benadryl. The eye was still swollen in the morning but less so than the night before. Now, 24 hrs after the symptoms began, the eye hive has almost entirely subsided. She feels less severe symptoms now, like fatigue and scalp tenderness.
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| 54 | 2021-03-21 | swollen tongue, mouth tingling |
Patient reported having trouble breathing, tongue swelling, tingling sensation on lips. States havin...
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Patient reported having trouble breathing, tongue swelling, tingling sensation on lips. States having this same reaction last time she used her prescribed epi pen . Administered epi pen at 12:55. Symptoms subsided after injection given in right thigh. Paramedics called and took her to nearest hospital for further evaluation.
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| 54 | 2021-03-21 | swollen tongue |
Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine admi...
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Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine administration Patient took her own Benadryl with resolution of symptoms.
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| 54 | 2021-03-21 | pain in jaw, mouth tingling |
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ...
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When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
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| 54 | 2021-03-22 | vision blurred |
After receiving my second dose, i started to feel very sick, by the second day after the vaccination...
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After receiving my second dose, i started to feel very sick, by the second day after the vaccination, I had a severe headache, my eyes couldn't focus i was nauseous and i was vomiting, sever upper body pains, it was the worst headache I have ever had in my life, my husband took me to the emergency room yesterday and i was there all day, I had a neurological exam, blood work and chest x-ray, everything came back negative, i was told my the attending physician that it was the side effects of the second dose of the Pfizer Vaccine. I was given Motrin 600mg and Metoclopramide via intravenous, several hours later, i was feeling a bit better and i was released from the hospital by 4:30pm.
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| 54 | 2021-03-22 | loss of smell, loss of taste |
Received dose 1 of Pfizer COVID-19 vaccine on 12/24/2020. On 12/27/2020 patient developed chills, ...
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Received dose 1 of Pfizer COVID-19 vaccine on 12/24/2020. On 12/27/2020 patient developed chills, body aches, cough, loss of taste/smell, and congestion
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| 54 | 2021-03-22 | ear pain, eye pain, ringing in ears |
The night of the injection I had a headache and chills no fever. In the morning my headache was a m...
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The night of the injection I had a headache and chills no fever. In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash. My ear was ringing and hurt It was painful to swallow. Went to ER and was Dx with shingles was prescribed valtrex 1gram q8 hours and lotramin lotion
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| 54 | 2021-03-23 | swollen tongue |
EMS narrative: NARRATIVE RESPONDED TOFE FIELD FOR A 54 YEAR OLD FEMALE HAVING ALLERGIC REACTION. AR...
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EMS narrative: NARRATIVE RESPONDED TOFE FIELD FOR A 54 YEAR OLD FEMALE HAVING ALLERGIC REACTION. ARRIVED ON SCENE TO FIND PT SITTING UPWRITE ON A BED. PT IS ALERT AND ORIENTED. PT DOES NOT APPEAR TO BE IN DISTRESS. STAFF MEDIC CLAIMS THE PT RECEIVED HER FIRST VACCINATION AND BEGAN TO HAVE A REACTION. PT STATES HER TONGUE BEGAN TO SWELL UP AND HAD DIFFICULTY BREATHING. STAFF STATES THEY GAVE THE PT BENADRYL AND SOLU-MEDROL. PT HAS ALREADY IMPROVED WITH THE MEDICATIONS. PT STATES SHE FEELS MUCH BETTER AND HAS NO SHORTNESS OF BREATH. PT SHOWS NO SIGNS OF ALLERGIC REACTION. PT WANTS TO BE TRANSPORTED. PT WAS ABLE TO STAND AND SIT ON THE COT WHERE ALL STRAPS AND RAILS WERE APPLIED. PT WAS BROUGHT TO THE AMBULANCE WHERE VITALS WERE ASSESSED AND MONITORED. PT WAS TRANSPORTED WITHOUT INCIDENT.T PT WAS BROUGHT INTO THE FACILITY WHERE CARE WAS TRANSFERRED TO RN.
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| 54 | 2021-03-23 | taste impairment | Metallic taste and L shoulder pain |
| 54 | 2021-03-24 | mouth tingling | Feeling "light" and tingling in hands and lips |
| 54 | 2021-03-24 | pain in jaw |
Within a couple of hours post shot I started getting a headache and had some stiffness and pain in m...
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Within a couple of hours post shot I started getting a headache and had some stiffness and pain in my head and jaw. When I woke up the next morning (18 hrs post shot) I was running a fever (highest documented was 100.4), body aches (felt like I had been hit by a truck), pounding headache and chills (couldn't get warm despite several blankets). This continued all day (hours 18-34 post shot). Fever broke around hour 34 and at hour 42 post shot all symtpoms have resolved.
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| 54 | 2021-03-24 | lip itchiness, bloodshot eyes |
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; ha...
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severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
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| 54 | 2021-03-25 | taste disorder |
Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was eva...
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Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was evaluated by an on-site EMT and symptoms resolved within 30 minutes. Patient has a history of panic attacks.
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| 54 | 2021-03-25 | mouth itchiness, lip swelling |
Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly i...
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Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly itchy. Little bumps around the edges of both upper and lower lips.
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| 54 | 2021-03-25 | ear pain |
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for...
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Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
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| 54 | 2021-03-26 | ear pain |
19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar ...
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19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar - Day 3 - no symptom 22nd Mar - Day 4 - no symptom 23rd Mar - Day 5 - no symptom 24th Mar - Day 6 - irritated throat after dinner 25th Mar - Day 7 - Sore throat, ear ache, full body and joints ache, temperature between 99 and 101, spoke to NP, was ordered Covid test 26th Mar - Day 8 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever), 27th Mar - Day 9 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever),
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| 54 | 2021-03-26 | ringing in ears, smell distorsion | Everything smells like rotting meat, ringing in my ears, body pains all the time. |
| 54 | 2021-03-26 | toothache |
Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. ...
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Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. I had rapid heartbeat for 2 1/2 weeks after the first dose and almost did not return for the 2nd dose because of this.
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| 54 | 2021-03-26 | dry throat |
Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tig...
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Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tightness, facial tingling. Given Epipen and albuterol. Sent to ED.
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| 54 | 2021-03-27 | dry mouth, eye irritation | Fever, chills, joint aches, headache, dry mouth, burning eyes, all body aches |
| 54 | 2021-03-28 | mouth numbness, mouth tingling |
This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I ...
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This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I have no idea what triggers it so it may not be vaccine-related Vaccine: 9am MT. About 25 minutes after the vaccine (9:25am) , my lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue. I waited 90 minutes then self-treated with two Benadryl tablets (11am). Tingle/numb were gone 1-1:30ish.
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| 54 | 2021-03-28 | mouth tingling |
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed...
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heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
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| 54 | 2021-03-29 | blindness in both eyes |
I did not have a reaction until I got home on Jan 4th, 2021. I had a headache for a solid 2 weeks. ...
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I did not have a reaction until I got home on Jan 4th, 2021. I had a headache for a solid 2 weeks. Lost my vision right eye on Feb 1st with extreme vertigo ended up in the hospital. After a few tests they found a heart defect ASD. Never in my life have I been told I have had a heart condition. I am correlating it to the vaccination because for the 4 solid weeks before I ended up in hospital I was so sick.
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| 54 | 2021-04-03 | ringing in ears | Ringing constant hissing in the ears. Never had tinnitus prior |
| 54 | 2021-04-04 | feeling of choking, mouth tingling | left side numbness and tingling throat 1/2 closed, right side lip |
| 54 | 2021-04-24 | eye pain, eye strain |
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so...
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passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-26 | mouth tingling |
The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is...
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The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-30 | visual impairment |
Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea;...
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Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea; Chills so bad I was hyperventilating; Chills so bad I was hyperventilating; This is a spontaneous report from a contactable consumer reporting for herself. A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 08:15 (Batch/Lot number was not reported) as single dose, Medical history included hypertension. The patient's concomitant medications were not reported. The Patient received the first dose of BNT162B2 vaccine on 23Mar2021. The patient experienced weakness on right side of body on 13Apr2021 19:00 with outcome of not recovered , extreme visual disturbances in right eye that won't go away on 13Apr2021 19:00 with outcome of not recovered , nausea on 13Apr2021 19:00 with outcome of not recovered , chills so bad I was hyperventilating on 13Apr2021 19:00 with outcome of not recovered. The events weakness on right side of body and extreme visual disturbances in right eye were considered Important Medical Events. The patient visited the ER because of the events and underwent CT scan, ultrasound, multiple medications. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 54 | 2021-05-05 | ringing in ears | Tinnitus I have always had Tinnitus but symptoms are worse after getting the vaccine. |
| 54 | 2021-05-10 | mouth numbness |
Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel num...
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Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; Within 24 hours the entire side of my face from my jaw to my eye was numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN0164 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 15Apr2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included bee venom (known allergies). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 15Apr2021 at 10:30 AM, she developed bell's palsy on the left side of her face. Her mouth and side of her face started to feel numb within a half hour of receiving the vaccine. Within 24 hours the entire side of her face from her jaw to her eye was numb. The patient received Medrol 4 mg dosepak and Valtrex - 7-day dose as treatment for the events. The events resulted in physician office visit. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 54 | 2021-05-11 | tongue discomfort |
Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so ...
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Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so that i could not breath well for a few seconds; Burning of the tongue from the tip then to the middle and towards the throat; Burning of the tongue from the tip then to the middle and towards the throat; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered on left arm on 08Apr2021 12:00 (Batch/Lot Number: Unknown) as unknown, single (at the age of 54-year-old) for COVID-19 immunisation. Medical history included undifferentiated connective tissue disorder and allergy to dust and pollen. The patient's concomitant medications were not reported. The patient stated on 08Apr2021 12:00, "burning of the tongue from the tip then to the middle and towards the throat. Tonsil kind of closes so that I could not breath well for a few seconds. They put me on oxygen, gave me Benadryl and Tacid". Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. No follow up attempts are possible; information on the lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported tonsillar disorder with symptom of dyspnea was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 55 | 2021-01-01 | mouth tingling |
Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own af...
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Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.
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| 55 | 2021-01-05 | loss of taste | Queasy No taste headache tight neck- stiff |
| 55 | 2021-01-05 | mouth numbness | Rash, chest pain, tachycardia, numb tongue, hard to swallow |
| 55 | 2021-01-07 | ringing in ears |
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o...
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Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
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| 55 | 2021-01-07 | lip swelling, eye pain |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | mouth tingling |
Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevac...
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Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevacid and symptoms went away.
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| 55 | 2021-01-07 | taste impairment |
at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shive...
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at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shivers that last over an hour. Fever of 101.5 at 1am in the morning. Head ache that was first in the temples and then went behind the eyes. Water had a metal taste to it. Did not take a tylenol or anything to relieve the fever or ache. I prefer to allow my body to fight it naturally. Used an ice pack at the nap of my neck to help with fever and also headache. Also took 2 showers to help with body ache. 1/8/21 12:20pm fever is still 100.4. Body is still achy with slight headache.
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| 55 | 2021-01-08 | taste impairment, pain in jaw | Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps |
| 55 | 2021-01-08 | swollen tongue | Patient felt tongue swell, and then her throat started to close. -Anaphylaxis |
| 55 | 2021-01-10 | vision blurred |
Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vi...
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Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vision appears to be impacted by viral infection and should resolve without intervention per ASC., also numbness surrounding orbit of left eye
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| 55 | 2021-01-10 | mouth numbness |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-10 | mouth tingling |
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du...
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lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
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| 55 | 2021-01-11 | eye swelling |
Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This i...
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Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut. The patient did received treatment as a result of the event with benadryl, aderol inhaler. The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.
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| 55 | 2021-01-12 | taste impairment |
Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth...
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Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth right after injection lasted 1 hour or so
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| 55 | 2021-01-12 | tongue discomfort | ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY |
| 55 | 2021-01-12 | mouth numbness, mouth tingling |
Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed...
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Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED. Upon arrival to ED, patient began to cough.
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| 55 | 2021-01-12 | pain in jaw | chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw |
| 55 | 2021-01-13 | ear pain |
Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling...
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Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling very cold/chills, and had fever of 102, also have headache, very tired. When she had fever her ear hurt.
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| 55 | 2021-01-13 | swelling around the eyes, dry throat |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | mouth numbness, mouth itchiness |
Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injecti...
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Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injection (left) and itchy in the mouth and numb in the tongue. Came to report to me (lead RPh for clinic) at 11:50am. I spoke with another staff member to get patient 50mg of benadryl. While I waited for the medicine, I inspected the patients arm, face and inside the mouth. No redness, swelling, hives or other signs/symptoms of allergic reaction. Arm looked normal, no discoloration. Same with face and inside mouth. Patient took 50mg Benadryl at 12pm. Patient also stated having sinus issues currently (before vaccination) and has had off/on reactions with flu shot and other vaccines, mainly itching in the arm that was injected and swelling at the injection site (grapefruit size). Patient reported feeling itchiness gone at 12:10pm but still having some numb tongue. By 12:23pm, patient reported feeling completely better and no more numbness in the tongue.
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| 55 | 2021-01-13 | mouth itchiness, swollen tongue, eye itchiness, feeling of choking |
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu...
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Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
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| 55 | 2021-01-14 | tongue disorder |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | ringing in ears |
Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 55-years-old fem...
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Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284, expiry date not reported), intramuscular on 06Jan2021 at a single dose into left arm as COVID prevention. There were no medical history and concomitant medications. Patient did not receive any other vaccines on the same day as the COVID Vaccine. Patient received the COVID shot on Wednesday (06Jan2021), and about two hours after she got the shot, she starting having godawful ringing in her ears that lasted the last two days. Patient confirmed that the product was not specifically prescribed to her, but rather it was given via workplace policy. The ringing in her ears started that same day (06Jan2021) and that the ringing has stopped, it stopped around 5:30 am morning of the report date (08Jan2021). Therapeutic measures were taken as a result of ringing in ears. Patient stated that she took Benadryl before bed last night (07Jan2021). The event ringing in ears recovered on 08Jan2021 at 5:30 am.
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| 55 | 2021-01-16 | mouth tingling |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-17 | lip swelling |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-17 | ear pain |
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid...
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Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
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| 55 | 2021-01-17 | vision blurred |
Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any heada...
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Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any headache. No other symptoms
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| 55 | 2021-01-19 | mouth tingling |
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ...
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I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
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| 55 | 2021-01-20 | taste impairment, mouth tingling, ear pain, mouth numbness |
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va...
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After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
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| 55 | 2021-01-20 | mouth numbness, taste impairment |
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG...
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HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
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| 55 | 2021-01-20 | mouth numbness |
Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowi...
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Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowing.
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| 55 | 2021-01-20 | ringing in ears |
Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. ...
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Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported. The vaccine was administered at Hospital Facility. It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists. The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-20 | toothache |
Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on m...
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Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on my whole left side of face did xray was referred to oral surgeon did exam and both confirmed it had to be a reaction to vaccine. was prescribed Flexural and Toradol Aleve. medication takes about an half hour to kick. been in bed for a week with ice on my face. Cant work at all.
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| 55 | 2021-01-20 | mouth tingling |
tingly lips; felt like throat was swelling; This is a spontaneous report from a contactable other hc...
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tingly lips; felt like throat was swelling; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 07Jan2021 14:30 at a single dose for COVID-19 immunization at the hospital. Medical history included high blood pressure and high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin, bupropion, and benazepril. The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. The patient experienced tingly lips and felt like throat was swelling on 07Jan2021 16:30 with outcome of unknown. The events resulted in emergency room/department or urgent care. Treatments were Medrol dose pack and Prevacid. The patient was not diagnosed with COVID prior vaccination and had not tested for COVID post vaccination.
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| 55 | 2021-01-21 | ear pain, eye pain | I had eye pain, headache, ear pain |
| 55 | 2021-01-25 | mouth tingling, mouth numbness |
Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and...
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Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and throat; Inflammation of the tongue and throat; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine for hypothyroidism. The patient previously took Demerol and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 08:30 AM, the patient experienced numbness and tingling of the lips, inflammation of the tongue and throat. No treatment was given to patient for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. Information on the lot/batch number has been requested.?
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| 55 | 2021-01-25 | mouth numbness |
Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP S...
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Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP SOLU-Medrol 125mg IVPB
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| 55 | 2021-01-25 | ear swelling |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-25 | lip swelling |
lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red a...
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lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
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| 55 | 2021-01-26 | pain in jaw |
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp...
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Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
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| 55 | 2021-01-26 | loss of taste, dry mouth |
does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a conta...
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does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 (last Friday of 13Jan2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient was calling for herself regrading side effects for the vaccine, she clarified the vaccine to be the COVID-19 Vaccine, the Pfizer one, she got the vaccine on 08Jan2021 (last Friday of 13Jan2021), she was having side effects, she was having issues with her mouth, her mouth was dry and issues with taste, she was losing it a little, she did not have much taste, she stated she had never had dry mouth before and she was trying to figure out if these are symptoms from getting the vaccine or something. The patient experienced mouth dry from 12Jan2021 and ongoing, losing taste a little on an unspecified date. She wanted to know if others had experienced these events. She stated these do not worry her too much, she then added she had heard that mouth dry is a side effect. The patient stated she did not not have a fever, no coughing, or aches. The outcome of the event mouth dry was not recovered, while unknown for the other event. Information about Lot/Batch number is requested.
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| 55 | 2021-01-26 | taste impairment |
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ...
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frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
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| 55 | 2021-01-26 | taste impairment |
mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soren...
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mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
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| 55 | 2021-01-26 | taste disorder, dry mouth |
mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable othe...
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mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.
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| 55 | 2021-01-28 | mouth tingling, feeling of choking |
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ...
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Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
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| 55 | 2021-01-28 | loss of smell, loss of taste |
Headache, fever, body aches, GI issues, cough feels like something is restricting the back of left l...
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Headache, fever, body aches, GI issues, cough feels like something is restricting the back of left lung when taking deep breath, no smell or taste.
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| 55 | 2021-01-28 | dry mouth |
Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have ...
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Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have difficulty swallowing ( constant need to clear throat), dry mouth, numbness & tingling in feet & legs. 2mL of dexamethasone 4mg/mL given IM to left deltoid by FNP. Epinephrine 0.3mg/0.3mL given IM to right upper thigh by FNP. Pt placed on 2LPM O2 via NC for comfort. Pt tolerated well. Pt recovered & left our clinic at 1635.
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| 55 | 2021-01-31 | loss of taste |
Report of fever, headache, body aches, lost of taste started day one post vaccination. Treatment: Ty...
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Report of fever, headache, body aches, lost of taste started day one post vaccination. Treatment: Tylenol and Ibuprofen. Outcome: body aches, fever and headache has improved. Fatigue and lost of taste remain unchanged.
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| 55 | 2021-02-01 | mouth numbness |
2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as ...
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2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as a constricted feeling in her throat with some difficulty swallowing. Patient was given 25 mg of Benedryl, and later, 40 my of Pepcid, and throat constriction went away but feeling of numbness remained for a while. Her BP generally runs high, but was elevated at 160/100 (1:20 pm), then lowered to 138/89 (1:52 pm). Patient returned to work at 2:06 pm after symptoms had resolved.
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| 55 | 2021-02-03 | swelling of eyelid, eye itchiness |
After an hour and a half to two hours after injection, I began to have an allergic reaction but it w...
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After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
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| 55 | 2021-02-03 | oropharyngeal discomfort |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-03 | ringing in ears, deafness |
Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by E...
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Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by ENT, TMJ specialist,allergist and her PCP. Hearing test revealed mild hearing loss in high frequency. 1/27/21 received the second dose of the vaccine. The following day she developed flu-like symptoms, including fever, chills, headache and fatigue and worsening of Tinnitus. Received Dupixent two weeks prior to the vaccine.
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| 55 | 2021-02-04 | eye pain, vision blurred |
Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site lim...
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Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site limiting movement, eye pain and blurring. All began approximately 12 hours after vaccination. Did report to the ER at Summit Medical Center 2/3/2021 . Labs were drawn, ekg and cxr done. Md stated all normal. (I had pneumonia and was in a fib upon arrival to Vanderbilt Medical Center when I was admitted there with Covid in March 2020.)
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| 55 | 2021-02-04 | loss of taste, loss of smell |
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache an...
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Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough. I took another dose of cough meds but it didnt work. That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home. Once home I was so tired and weak I could barely make it to the couch. My temp then was 101 so I laid down. The couch was so bad it caused my throat to begin to hurt. I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly. I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
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| 55 | 2021-02-04 | mouth tingling | Tongue tingling /numbness Diaphoresis Clammy skin Lightheaded Facial flushing |
| 55 | 2021-02-06 | toothache, ear pain |
3rd day after vaccine, I had severe sore throat on left side, teeth ached on left side, ear ache on ...
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3rd day after vaccine, I had severe sore throat on left side, teeth ached on left side, ear ache on left side, no fever, but severe fatigue. Two weeks after I had the 1st vaccine, I ate shell fish. 30 to 45 minutes later, I had a terrible reaction. I had a bad back ache. I felt like I was going to faint and felt very dizzy. I had severe diarreha and had hot flashes and forehead sweats. I barely made it to my bed and went to sleep.
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| 55 | 2021-02-06 | mouth numbness, mouth tingling | numbness and tingling of tongue 45 minutes following |
| 55 | 2021-02-07 | loss of smell, loss of taste |
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C...
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PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
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| 55 | 2021-02-07 | mouth tingling, taste impairment, mouth numbness, feeling of choking |
Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe...
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Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
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| 55 | 2021-02-07 | taste impairment |
Ten minutes post receiving vaccination pt reported metallic taste in mouth and 'funny feeling in thr...
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Ten minutes post receiving vaccination pt reported metallic taste in mouth and 'funny feeling in throat' that made her constantly need to clear her throat.
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| 55 | 2021-02-07 | lacrimation increased, eye itchiness |
itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the seco...
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itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the second dose; nipple drainage/increased again after the second dose; exhausted; nausea; low grade fever; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 30Dec2020 for COVID-19 immunization and experienced nipple drainage, sore arm, metallic taste in mouth, itchy and watery eyes. The nipple drainage decreased before getting the second dose, and then increased again after the second dose. She noticed an increase in the drainage on 21Jan2021. It was a yellowish to clearish drainage. She was wondering if there was any correlation. She was curious if other women have noticed this. She was unsure of her weight, but would get 140 or 150 lbs. She didn't have a prescribing doctor. She got it through her employer. Also she experienced other side effects. After the second dose she experienced different side effects. She experienced a low grade fever. It started on 19Jan2021 evening into 20Jan2021 morning. It lasted for 18- 24 hours. She recovered completely, and it was not serious. She also developed muscle aches on 19Jan2021, 6-8 hours after the second vaccine. She felt better now. She had a rough night last night. She has been doing Advil, and it had helped significantly. That stated on 19Jan2021. It had improved, and it was not serious. She had also been exhausted after the second vaccine. That started 20 hours after. It started the 20Jan2021. It was ongoing, but had improved. It was not serious. She developed the nausea six hours later on the 19Jan2021. It had improved, but she was not 100%. It was not serious. She had been taking Tylenol and Advil for event low grade fever and muscle aches. She had noticed an increase in the itchiness and watery eyes (She didn't know if it was related to winter and allergies or the vaccine.). It was ongoing and persisting. The outcome of the event low grade fever was recovered on 20Jan2021, of the events muscle aches, exhausted, nausea was recovering, of the events itchiness and watery eyes was not recovered, of the other events was unknown.
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| 55 | 2021-02-07 | eye itchiness, taste impairment, lacrimation increased |
nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a s...
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nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
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| 55 | 2021-02-08 | lacrimation increased |
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running co...
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A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
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| 55 | 2021-02-08 | lip swelling, mouth tingling, swollen tongue |
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset....
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Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
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| 55 | 2021-02-09 | ringing in ears |
getting a weird ringing, buzzing noise in the ears that keeps coming and going; This is a spontaneou...
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getting a weird ringing, buzzing noise in the ears that keeps coming and going; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 17:00 (at the age of 55 years old), as a single dose (Dose 1) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine at 5PM "yesterday" (20Jan2021) and did fine. This morning (21Jan2021) at 10AM she experienced getting a weird ringing, buzzing noise in the ears that keeps coming and going. She has never had this before. The clinical outcome of the event(s) was not reported. She wanted to know why she is getting this and if it was normal at this point. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 55 | 2021-02-10 | vision blurred | Clouded vision in one eye |
| 55 | 2021-02-10 | burning mouth syndrome |
Tongue was sore on the left side. I had a knot under my chin.. In about 8 hours the knot tripled the...
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Tongue was sore on the left side. I had a knot under my chin.. In about 8 hours the knot tripled the size looked like a large lymph Node under my chin I went to see a ENT within a week and they stated that my lymph was clogged and congested around the tissue which caused saliva gland to become clogged which causes Salisbury stones in my tongue
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| 55 | 2021-02-11 | mouth tingling, lip swelling |
This happen within :15 minutes of the shot. Tongue tingle and swell with lips then nurse gave benad...
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This happen within :15 minutes of the shot. Tongue tingle and swell with lips then nurse gave benadryl took the ER to be checkout byt the doctors . The observed and did an EKG and sent home after observation .
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| 55 | 2021-02-16 | extreme sound sensitivity |
About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the compute...
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About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the computer could not remember what to do next as I searched for needed files. At the end of the day, I signed off my computer but needed to think about how to turn off the monitor. The next day was better, but by the 3rd day out I became very sensitive to sound. On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion. This continued for two whole days and I could not sleep at night due to the intensity of my headache. All of this could have been a migraine which I had in the past, but never to this extent. Past migraines were visual in nature and only lasted about an hour. By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
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| 55 | 2021-02-18 | lip swelling, mouth tingling |
Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the d...
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Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the dentist". Given 50 mg Benadryl. Numbness continued to spread through that side of face, EMS called, transported to ER.
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| 55 | 2021-02-21 | vision blurred |
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H...
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FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
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| 55 | 2021-02-23 | mouth pain |
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time....
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At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
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| 55 | 2021-02-23 | taste disorder |
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me...
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Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
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| 55 | 2021-02-24 | taste impairment |
Metallic taste in mouth, no other sx. Hx of anaphylaxis. Evaluated by EMS. So resolved and cli...
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Metallic taste in mouth, no other sx. Hx of anaphylaxis. Evaluated by EMS. So resolved and client was discharged at 1:55pm.
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| 55 | 2021-02-24 | mouth tingling |
Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, i...
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Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, in eyebrows, inside eyes, on pupils of eyes, on lips, inside mouth, on ear lobes, inside ears, on nose, inside nostrils; tingling in tongue, runny nose, extreme fatigue, wooziness, challenges speaking at times,, itching. It is progressing to a different membrane everyday and I am not receiving any assistance.
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| 55 | 2021-02-25 | mouth numbness | Tightness in throat, numbness around mouth. Zytec 10mg po given |
| 55 | 2021-02-28 | swelling of eyelid |
Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved i...
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Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved inn48 hours
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| 55 | 2021-03-01 | vision blurred, swollen tongue |
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness...
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Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
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| 55 | 2021-03-02 | visual impairment | vision changes Sent to Emergency dept for further observation |
| 55 | 2021-03-03 | mouth tingling |
C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had ...
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C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had itching in her arm. After second co-vid vaccine had a headache for 2 weeks, now has a rash that comes and goes on her antecubital area.
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| 55 | 2021-03-04 | dry eye, thirst |
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, na...
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March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
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| 55 | 2021-03-05 | ear pain |
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congesti...
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Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congestion, headache, earache
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| 55 | 2021-03-07 | mouth tingling, taste disorder |
Immediately after IM injection, patient stated she had a funny taste and reported lips felt like the...
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Immediately after IM injection, patient stated she had a funny taste and reported lips felt like they were tingling. Patient then began having difficulty breathing with throat swelling. Patient was unable to swallow and had difficulty speaking. Epinephrine was administered and EMS was notified. Patient improved after epinephrine administration and was transported by EMS to hospital.
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| 55 | 2021-03-07 | loss of taste, loss of smell |
Lost senses of smell and taste other than extremely strong tastes and odors (vinegar) for approximat...
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Lost senses of smell and taste other than extremely strong tastes and odors (vinegar) for approximately 24 hours. Noticed symptoms improving and completely recovered about 26 hours after initially noticed
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| 55 | 2021-03-08 | tongue itchiness | Pt reports itchy tongue and lightheadedness. no h/o DM, no meds taken today. juice given |
| 55 | 2021-03-08 | inability to speak, visual impairment |
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate...
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Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
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| 55 | 2021-03-09 | mouth tingling |
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started ...
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I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling, (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
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| 55 | 2021-03-09 | visual impairment, dry eye, eye floaters |
Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick u...
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Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick up food for supper. While waiting for the food, I was seeing spots (like when you have a photo taken with a flash). This lasted for about 20 minutes. This went away so I continued on my way home. As I was driving I notice that my face was tingling and my eyes seemed to be really dry. Both lasted about 30 minutes. Then I had the headache, arm soreness and light headedness that are "normal" side effects.
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| 55 | 2021-03-10 | eye swelling | Acute urticaria. Eyes swelled almost closed. Had trouble keeping them open. |
| 55 | 2021-03-10 | lip swelling |
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h...
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Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
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| 55 | 2021-03-10 | mouth tingling |
Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next d...
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Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next day. Tingling in the mouth for about an hour and a half on the same day.
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| 55 | 2021-03-10 | mouth pain |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-11 | ringing in ears |
Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt...
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Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
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| 55 | 2021-03-11 | eye pain, swelling around the eyes |
puffiness of eyes, especially left eye. Also bag and dark circle under left eye. Eye balls feel sor...
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puffiness of eyes, especially left eye. Also bag and dark circle under left eye. Eye balls feel sore
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| 55 | 2021-03-13 | mouth pain | Full body hypersensitivity rash with oral involvement, starting 3 days after vaccination. |
| 55 | 2021-03-13 | mouth pain |
Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination...
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Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination.
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| 55 | 2021-03-14 | eye itchiness |
3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLIN...
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3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLING OF MOUTH, TONGUE OR THROAT. GIVEN BENADRYL 50MG PO. PT STATES SHE 'FEELS OK TO GO HOME WITH HUSBAND'. HUSBAND TO DRIVE PT HOME. PT A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY BRISK/STEADY. NO ACUTE DISTRESS NOTED. 3-15-21 10AM TC: 'STILL HAS VERY SLIGHT RASH, NO OTHER SYMPTOMS'. CHECK WITH PCP R/T DOSE #2.
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| 55 | 2021-03-14 | swollen tongue, lip swelling, ear discomfort |
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness...
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About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
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| 55 | 2021-03-14 | feeling of choking, mouth tingling |
Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis pr...
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Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis protocol. Days later nausea w dizziness. By day 6 sudden onset of vertigo, diagnosed as vestibular neuritis. PT, supportive meds, continued dizziness.
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| 55 | 2021-03-14 | ringing in ears, deafness unilateral, hearing loss |
Impaired hearing started on 3/8/2021 in left ear only. Ringing in ear all day on 3/11/2021. Loss o...
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Impaired hearing started on 3/8/2021 in left ear only. Ringing in ear all day on 3/11/2021. Loss of hearing progressed each day in left ear. Had doctor appointment on 3/15/2021. Per Doctor, PCP, both ears look clear. Gave referral to see a specialist to check middle ear.
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| 55 | 2021-03-15 | mouth pain |
Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore ...
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Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore when biting down on anything, slightly throbbing otherwise. Day 4- soreness in temple subsiding
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| 55 | 2021-03-15 | eye disorder, mouth tingling |
Patient reported tongue heaviness but no swelling. No trouble breathing and extreme tiredness immedi...
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Patient reported tongue heaviness but no swelling. No trouble breathing and extreme tiredness immediately following shot. Patient said she could not open her eyes due to tiredness. No other side effects/adverse reaction reported. Monitored for 30 minutes and no medication administered.
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| 55 | 2021-03-15 | ringing in ears | Ringing in the ears began a few days after the vaccine and has continued |
| 55 | 2021-03-15 | mouth numbness, mouth tingling |
Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on t...
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Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area. These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea. I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided. After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
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| 55 | 2021-03-17 | swollen tongue, lip swelling, tongue disorder, ear discomfort |
Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, staye...
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Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue. Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips. Lisinopril d/c'd on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak. Allergist recommends no further COVID vaccines.
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| 55 | 2021-03-17 | eye itchiness |
Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started it...
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Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started itching. About 45 minutes later my right eye was itchy. I took two Benadryl tablets and decided to work from home. I drove home and took a nap. When I woke up the rash and itching were gone.
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| 55 | 2021-03-17 | taste impairment |
Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adv...
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Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adverse impact from having this side effect.
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| 55 | 2021-03-17 | lip swelling |
Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next d...
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Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next day
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| 55 | 2021-03-18 | taste impairment |
A few hours after first dose I began having a metallic taste in mouth. This lasted for several hours...
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A few hours after first dose I began having a metallic taste in mouth. This lasted for several hours, even through sleep. Also had zero food or appetite all day, despite trying, even after metallic taste dissipated. FYI: my boyfriend, who completed both shots of this same brand, said he also had weird taste in mouth.
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| 55 | 2021-03-18 | lip swelling |
AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING R...
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AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING RESOLVED ABOUT 15 MINS AFTER ONSET AND THE FACIAL SWELLING ABOUT AN HOUR AFTER ONSET.
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| 55 | 2021-03-18 | mouth tingling, dry throat | itchy scratchy throat with mild tingling sensation around lips |
| 55 | 2021-03-19 | eye itchiness |
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and ...
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Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
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| 55 | 2021-03-19 | mouth pain |
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai...
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With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
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| 55 | 2021-03-20 | taste impairment, mouth discomfort |
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in...
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A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
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| 55 | 2021-03-20 | mouth numbness |
Patient reported feeling numbness to the lips, mouth, upper palate and throat as well as feeling lik...
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Patient reported feeling numbness to the lips, mouth, upper palate and throat as well as feeling like someone was "choking her". She didn't appear to be in respiratory distress but reported that she had had a severe allergic reaction to the shingles vaccine one month ago, and that these were the same symptoms she felt at that time before it escalated. Patient was given epinephrine autoinjection 0.3 mg to the right thigh and EMS was called. Patient was transferred to ED. Patient remained conscious, breathing stable and able to speak the entire time.
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| 55 | 2021-03-21 | taste impairment, mouth tingling |
1508 C/O LIPS TINGLY METALLIC TASTE MONITORED, BP 142/98 SAT 97% HR 70 1533 148/98 96% 67 1548 148/...
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1508 C/O LIPS TINGLY METALLIC TASTE MONITORED, BP 142/98 SAT 97% HR 70 1533 148/98 96% 67 1548 148/99 99% 70 1603 146/100 98% 66 Did not want Benadryl pt told family she will be driving home. encouraged to seek medical help if s/s worsen pt call for an appt with MD this week.
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| 55 | 2021-03-22 | mouth numbness |
After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of ...
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After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of my chin/cheek and general nausea. The numbness proceeded up the left side of my face w/no visible drooping, and also included my left arm, left leg and left side of my tongue. Numbness level was like what it feels like as dental novocaine wears off. Went to ER and had CT scan, bloodwork, and an MRI which ruled out any stroke concerns. Monday, day after vaccine, I was tired (understandably since in the ER until 4 AM Monday) and had some residual numbness, mostly on my face, some on my arm/leg. Nausea went away after an hour or so on Sunday afternoon and I ate variety of food w/no issues on Sunday and forward. Still have some of the numbness sensations as of Tuesday, mostly feel it in my face. Overall, it feels like half my body got the vaccine and the other half wasn't impacted.
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| 55 | 2021-03-22 | eye swelling |
Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium ...
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Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium first episode. Second episode was seen by dr - dose pack, famotidine, Benadryl, rescue inhaler were prescribed..
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| 55 | 2021-03-22 | taste disorder, mouth swelling |
Throat swollen and inside cheeks swollen, no taste tongue and cheeks feel burning sensation when eat...
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Throat swollen and inside cheeks swollen, no taste tongue and cheeks feel burning sensation when eat or drink.
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| 55 | 2021-03-23 | vision blurred |
2:35 pm Client presented self w/ c/o feeling a bit lightheaded. no c/o blurred vision. Respiration...
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2:35 pm Client presented self w/ c/o feeling a bit lightheaded. no c/o blurred vision. Respiration even and reg. B/P 190/98, HR 94. Paramedics present. 2:45 pm stated feet better, allowed to leave observation area.
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| 55 | 2021-03-25 | swollen tongue, ringing in ears, mouth itchiness |
55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for...
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55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for 15 minutes without any symptoms. She left the facility, but returned a few minutes later with complaints of dizziness, nausea, thick tongue, and itching palate. Upon assessment, vitals were BP 145/83, HR 83, SpO2 99%. Given diphenhydramine 25 mg solution. Shortly thereafter, pt experienced increasing tongue thickness and chest tightness. Epinephrine 0.3 mg auto injector administered followed by famotidine 20 mg and hydrocortisone 100 mg. Continued dizziness, ear ringing, SpO2 83%. EMS called and patient transferred to the ED. Presented to the ED without symptoms and observed for 4 hours. Discharged home with...
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| 55 | 2021-03-25 | lip swelling, swollen tongue |
After minutes of observation, pt was driving home, at about 35 minutes after vaccine was administere...
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After minutes of observation, pt was driving home, at about 35 minutes after vaccine was administered pt felt thickening of tongue, feeling tightness in throat, lips feeling thick, stopped at a pharmacy bought OTC allergy medicine Zyrtec , took it & went home. Also took Benadryl when she go home
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| 55 | 2021-03-25 | mouth tingling, mouth numbness |
Approx 30 minutes after vax my lips started tingling and became numb. Approx 45 minutes after vax m...
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Approx 30 minutes after vax my lips started tingling and became numb. Approx 45 minutes after vax my tongue became tingly and numb. Two hours later the condition was the same. I took an herbal antihistamine and it reduced a bit. By approx 10:00am the next morning the tingling and numbness was gone.
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| 55 | 2021-03-25 | eye bleeding |
Client reported a ruptured blood vessel in her right eye following vaccine administration. Client w...
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Client reported a ruptured blood vessel in her right eye following vaccine administration. Client was evaluated by Fire Rescue. Client was released to go home at 3:59pm. Per Fire Rescue patient does not need further onsite eval.
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| 55 | 2021-03-26 | eye itchiness |
A few minutes after the injection patient developed left eye itching and throat scratchiness (approx...
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A few minutes after the injection patient developed left eye itching and throat scratchiness (approximately 0905). Vitals at 0913: 104/74 BP, 74 HR, 98.3 temp, 100 % oxygen saturation. Gave 50 mg oral Benadryl at 0916. Vitals at 0918: 100 % oxygen saturation, 111 HR, 133/71 BP, chest heaviness noted at this time. Vitals as of 0923: 114 HR, 100 % oxygen saturation, 122/83 BP. Patient transported to Emergency Room.
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| 55 | 2021-03-26 | taste impairment |
Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal...
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Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
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| 55 | 2021-03-27 | mouth tingling | Pt felt dizziness noted with lip tingling |
| 55 | 2021-03-27 | swollen tongue, mouth numbness |
Within the first few min of getting the injection my throat got tight and my tongue swelled up and g...
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Within the first few min of getting the injection my throat got tight and my tongue swelled up and got numb. I could still breathe fine. Didn't need any additional help. Throat cleared up after a few hours. Tongue still numb and swollen a bit for around 4 days after. Each day got better but took a few days for it to return to normal. Still having some occasional numbness on day 5 but not swollen and only on the edge of tongue. At this reporting I seem to have mostly recovered. I had a video conference with my doctor a couple days after to discuss my reaction.
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| 55 | 2021-03-29 | pain in jaw, ear pain, ear discomfort |
right ear irritation moving to ear pressure to ear pain behind ear lobe; right ear irritation moving...
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right ear irritation moving to ear pressure to ear pain behind ear lobe; right ear irritation moving to ear pressure to ear pain behind ear lobe; headache; right side of mouth canker sore; right side of head jaw pain; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route on 11Feb2021 at 12:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included erratic blood pressure and Von Willebrand Syndrome. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine and hydrochlorothiazide from unspecified dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL9261) on 20Jan2021 at 11:30 as a single dose in the left arm for COVID-10 immunization. The patient did not have any allergies to medications, food, or other products. On 19Feb2021 at 07:00 the patient experienced right ear irritation moving to ear pressure to ear pain behind ear lobe, right side of mouth canker sore, right side of head jaw pain, and headache. The patient visited a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcomes of right ear irritation moving to ear pressure to ear pain behind ear lobe, right side of mouth canker sore, right side of head jaw pain, and headache were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 55 | 2021-03-30 | pain in jaw, toothache, mouth pain |
Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/...
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Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered Information on Lot/Batch number has been requested.
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| 55 | 2021-03-30 | ear pain, ear discomfort |
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec...
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Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
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| 55 | 2021-03-30 | double vision, eye disorder |
hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy bey...
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hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy beyond itch; Anaphylaxis; Double vision; Right eye is going cross eyed/Left eye is dropping; Right wrist pain increased dramatically after the vaccine; Throat starting to close/Throat started tightening; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Feb2021 10:00 (Batch/Lot Number: EN6201), at the age of 55 years, as single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 3 years ago, ongoing gastrooesophageal reflux disease diagnosed 4 years ago, ongoing hypertension diagnosed 4 years ago, ongoing food allergy: allergic to eggs, shellfish, dairy/lactose intolerant, ongoing allergies to environmental: standard- hay fever, dust, mold, ongoing allergies to dogs and cats, contrast media reaction (IV contrast CT scan dye- respiratory distress, throat tightens), urticaria, pruritus. She had Covid on 18Dec2020 and "Covid rash it attached her muscular system. She had muscular pain in the wrist and hip on the right side and mild double vision." The patient previously took vitamin k 2 and experienced anaphylactic reaction, Toradol and experienced urticaria, influenza vaccine and experienced rash at the injection site, at the age of 34 years (because she's allergic to eggs). The patient received the first dose of bnt162b2 on 29Jan2021 Lot: EL3247; 9:30 AM; Right arm for covid-19 immunisation and she did not have any symptoms whatsoever with the first shot. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. Vaccination Facility Type: Hospital. Concomitant medications included omeprazole taken for gastrooesophageal reflux disease; lisinopril taken for hypertension; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (INHALERIN) taken for asthma; start and stop date were not reported for all. The patient experienced anaphylaxis on 26Feb2021 with outcome of unknown, throat starting to close/throat started tightening on 19Feb2021 with outcome of recovered, severe rash- latus stranding, purple dots, and hives from face all the way down to toes on 19Feb2021 with outcome of not recovered, double vision on 20Feb2021 with outcome of not recovered, right eye is going cross eyed/left eye is dropping on 20Feb2021 with outcome of not recovered, right wrist pain increased dramatically after the vaccine on 20Feb2021 with outcome of not recovered, hands got very swollen and rash and itchy beyond itch on an unspecified date with outcome of unknown for Hand swelling and recovered for Localised itching. Therapeutic measures were taken as a result of the events: Benadryl, Zyrtec, Pepcid, New glasses for double vision, Prednisone 7 day ween. The patient underwent lab tests which included Hematology test on unknown date with unknown results; Immune markers on 11Mar2021 with unknown results. Clinical course: The patient received the vaccine on 19Feb2021at 10:00 AM and five minutes after, her throat started tightening and they put her in observation for another hour and then her throat felt fine and they let her go. Caller confirmed she was not referring to this occurrence as anaphylaxis. The anaphylactic reaction occurred days later. She mentioned from 19Feb2021-26Feb2021, her symptoms were progressing and then on 26Feb2021, it was full blown out; the actual anaphylaxis was 26Feb2021. Between this, she had severe double vision, severe rash from face all the way down to toes, one eye going cross eyed (right eye), left eye is still drooping. On 20Feb2021, she started having double vision that started with the sunlight and fluorescent lights and the next day she couldn't see anything without double vision, and her eye started going cross eyed. She still cannot see normally now. She is under eye doctor care for that too. The patient was treated with Epi-Pen into leg and then into the Emergency Room. She received 50 mgs of Benadryl and 125 mg of Solu-Medrol IM injection, but still have to give Epi because her throat was still closing. Her airway was intact and no nebulizer treatment needed. The patient reported also that her hands got very swollen and rash and itchy beyond itch. The patient reported that her weight at that point was 204, the she had been on Prednisone for a week, and her weight has gone up to 210 now. After her throat closed on the 26Feb2021, caller reports she gained 7 pounds while on it for one week. Caller stated she was also put on prednisone when she got diagnosed with asthma, reactive airway. She confirmed her throat stop closing immediately after the Epi. The patient was also treated with 25 mgs of Benadryl, Zyrtec, and Pepcid a day. Outcome for throat closing was improved with medication. Outcome for rash was not improved and she is taking medicine to counteract it; itch went away when she took the Zyrtec. Regarding right wrist pain, it increased dramatically after the vaccine. Caller reports it felt like a spiral fracture down the ulna and it started to ache on 20Feb2021, by the next day it hurt a 5 out of 10. By 22Feb2021, she was wearing a splint, it was 8 out of 10, and she felt like she fractured it and it was swollen on the ulnar side. Regarding eye disorder, she is now under the care of an eye doctor for her severe double vision, eye crossing, and eye drooping. The blurred eyes give bad balance and that kind of stuff. The cross eyedness gives her poor peripheral vision and also her depth perception has now been compromised. They say the glasses will fix it. As of 22Feb2021, a new pair of special lenses with prisms were ordered for her. The patient was not hospitalized.
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| 55 | 2021-04-01 | swollen tongue |
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al...
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her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
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| 55 | 2021-04-03 | ringing in ears, ear discomfort, hearing loss |
Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or som...
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Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or some noise is painful. This has been nonstop since 2-3 days after 1st vaccine. Have taken Claritin, pseudoephedrine as well as Benadryl to relieve the ear fullness, no relief.
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| 55 | 2021-04-04 | mouth tingling, tongue itchiness, mouth itchiness |
About an hour after receiving the vaccine I developed a large white hive just below the injection si...
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About an hour after receiving the vaccine I developed a large white hive just below the injection site. (hive approx 2 inches in diameter) I began to itch on rest of body/ no more hives just itch. I took 50mg of Benadryl. 4 hours later still itching so I took 50mg of Benadryl. Approx, 4.5 hours later, woke up with tightening feeling in throat, itching in throat and roof of mouth, itching tingling of tongue, and tingling sensation of lips. went to the emergency room. Was admitted and monitored, benadryl was administered. Duration of hospital stay 1 day.
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| 55 | 2021-04-06 | lip swelling |
felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Ups...
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felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
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| 55 | 2021-04-08 | toothache |
March 29, approximately 4:30 PM, I began to experience chills and body aches, and noticed my teeth f...
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March 29, approximately 4:30 PM, I began to experience chills and body aches, and noticed my teeth felt sensitive when I ate dinner. March 30, upon waking: Chills and aches were gone, but by 10 AM, my teeth continued to get more and more sensitive (it felt like I had been hit on the right side of my mouth) and my gum tissue became bulbous and sore around the sore teeth (6,7,8,25,26,27) and I wondered if I cracked a tooth somehow. However, the pain radiated to the right posterior teeth, and crossed to both incisors (top and bottom) on the left side. I would describe the pain as throbbing and acutely sensitive to room temperature air, pressure, hot and cold. this happened in a very short span of time, and I was awake and not clenching or grinding my teeth. March 30, afternoon: I called my dentist. He was out of town. I posted on social media, asking if anyone has had tooth pain post vaccine. There were a handful of anecdotal stories (first hand) with a similar issue, so I decided to wait and see if my issue would resolve similarly. April 6: Pain has been intermittently severe and dull over the past week. I see my dentist this afternoon to do an evaluation. He says the tissue looks odd - almost like a herpetic lesion trying to heal, both around tooth 26 and on the palate adjacent to 8. Also, it appears there is no longer any keratinized gum tissue around 26, and the tissue had receded dramatically on this tooth. The doctor takes photos and refers me to a periodontist for a tissue graft to save the tooth. April 9 (today): I have an appointment with a periodontist next week for an evaluation. My dentist assures me the area will need a graft. Today I have less pain, but the gingival inflammation around 26 has persisted. Since I don't know the outcome at this point, I can only hope that tooth 26 can be saved with a facial graft, but that is the course of action.
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| 55 | 2021-04-09 | eye disorder |
in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightne...
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in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.
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| 55 | 2021-04-12 | lacrimation increased |
All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot o...
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All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot out right side. Next day same thing with blurred speech. I went to hospital, had CT n MRI. No blood clot determined its bells palsy. I have been healthy accept for mild seasonal allergies
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| 55 | 2021-04-12 | vision blurred, pain in jaw |
When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoul...
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When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
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| 55 | 2021-04-13 | eye floaters, visual impairment |
1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO T...
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1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO THE HOSPITAL AND HAD A ULTRASOUND OF THE EYE TO CHECK FOR HEMORAGE BEHIND EYE. IT WAS CLEAR. FOLLOWED UP WITH EYE SPECIALIST THE NEXT DAY AND WAS DIAGNOISED WITH Posterior Vitreous Detachment. I HAVE NOW SEVERAL LARGE FLOATERS IN THE EYE.
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| 55 | 2021-04-13 | eye pain |
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri...
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The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
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| 55 | 2021-04-14 | vision blurred |
I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero s...
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I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero side effects. The night after that initial dose. I began having what I'd term as cognitive issues. Trouble focusing. Blurred vision. Confusion. My synapsis weren't synapping. My brain and mouth didn't work. I felt like inside my body was shaking. But visibly, outside, was nothing. At that time, I was managing diabetes and I figured it was related to victoza being stopped since I'm not a diabetic now. And it continued about 7 days. Then, dwindled for a few, but it returned. I then began getting panicked about it and having panic attacks. I'm afraid of dementia, and remembering was an issue. It continued 4 days off 4 days on. Oddly enough. The 3rd week, it went away about 3 days in. I had about 7 days of bliss, but on the 4th day I got vaccination number 2. At this point, troubleshooting, I quit all my medications. I thought the issue was meditation related. I got shot number two and 3 days later, it hit and stayed again. 4 days on. 4 days off. By this time, I figured it is not my medications. So I went to my Dr. We did an MRI. Carotid workup. We did every test known to man, inluding heavy metals and found no anomalies except I was dehydrated. So I increased water and raised kidney functions. Weeks went by like this. Off and on. Dr finally told me I had toxic metabolic encephalopathy and I could have died. All testing rules out everything except vaccination reactions. He said my body didn't recognize the vaccine and that my brain attacked the toxins and swellee and caused the TME because of that. I want others to know. TMEs can be deadly. Your brain can swell, and you can die. Fortunately I'm on the upswing. But I still worry about memory. I forget appointments. I still am for the vaccinations. But we never know how our own bodies will react. My physicians diagnosis is a TME caused by Pfizer vaccine. He has ruled everything else out. I advocate this vaccinaction. Do it. I think what I went through is rare. But interestingly enough, online, it states 23 percent of covid victims get TME. I didn't have Covid. I've tested negative. This is also not dementia or anything of that nature. I've been thoroughly examined.
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| 55 | 2021-04-14 | taste impairment | Metallic taste in mouth, chest pains |
| 55 | 2021-04-15 | pain in jaw |
First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot sam...
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First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot same fast heartbeat seemed to subside but I was tired. Next day it felt as if someone threw a fast pitch softball at my chest took my breath away seemed to last several minutes then extreme heartburn set in. Very fatigued, heart burn lasted 9 days. Starting on 4/5/21 joint pain also started in my new hip. On 4/12/21 jaw pain set in at which point went to urgent care.
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| 55 | 2021-04-15 | sensitivity to light, double vision |
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ...
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fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
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| 55 | 2021-04-16 | visual impairment |
On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my v...
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On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my vision was changing so I called my daughter to come stay with me and took tylenol fast release capsules. I went to bed and woke up the next morning with the same headache so I asked my daughter to take me to urgent care. Upon arrival they did a Covid test. I told them about my previous stroke in July 2020 and that I had a PFO closure done in October and have been on Plavix (clopidogrel) since then so I wasn't worried about stroke. The dr sent me to the ER immediately and they performed an MRI scan and told me I had suffered a new stroke due to blood clot.
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| 55 | 2021-04-17 | vision blurred |
Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing...
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Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing flares; Blurry vision / blurriness; This is a solicited report received from a contactable consumer based on information received by Pfizer. This solicited report (USASL2020210290) was reported to Amgen on 23/DEC/2020 by a consumer from a commercial program (PSP00086) and involves a 55 years old, female patient whose injections burn like crazy [PT: injection site pain] and blurry vision/blurriness [PT: vision blurred] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient's injections burn like crazy. For past three and a half to four weeks in Nov2020, the patient has had blurry vision. The patient saw an Ophthalmologist who stated everything looked fine with her eyes but blurriness persists. No treatment information was received. The outcome of the event vision blurred was reported as not recovered/not resolved. The outcome of the event injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain and vision blurred. The causal relationship between the events injection site pain, vision blurred and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. ADDITIONAL INFORMATION RECIEVED ON 02Apr2021: This case is upgraded to serious. In this follow up, the patient was experiencing flares [PT: rheumatoid arthritis], injection is extremely painful [PT: injection site pain], rash at the injection site [PT: injection site rash] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medications included covid-19 vaccine. On an unknown date, the patient reported that each injection was extremely painful and she gets a rash at the injection site with almost every dose. On 09Mar2021, she has been experiencing flares since having a COVID vaccine on 09Mar2021. She was not home to provide lot. No treatment information was received. The outcome of the events injection site pain, injection site rash were reported as not recovered/not resolved. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site rash and rheumatoid arthritis. The causal relationship between the events injection site rash, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts were possible. No further information was expected. Amgen's causality assessment: events injection site pain and injection site rash were related to etanercept, while events blurry vision and rheumatoid arthritis flare up were unrelated to etanercept. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual case report does not change the safety profile of the product.; Sender's Comments: Based on information provided, the time association and vaccine's safety profile, the possible contribution of suspect BNT162B2 to the events rheumatoid arthritis flare up ,injection site pain and injection site rash cannot be excluded. The event blurry vision occurred prior to the administration of vaccine BNT162B2, considered unrelated to vaccine injection. The causal relationship of the drug etanercept to the events injection site pain and injection site rash is possible given the implied time association, while the events blurry vision and rheumatoid arthritis flare up were assessed as unrelated to etanercept. The rheumatoid arthritis would involve in eye's disorder when the rheumatoid arthritis is in active status. The clinical course of rheumatoid arthritis would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-04-19 | ringing in ears | Have tinnitus in LEFT ear. Constant low roaring. Still present and not lessening at this time. |
| 55 | 2021-04-24 | eye swelling |
Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Ca...
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Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Care Professional (reporting on her-self). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP6955 and Expiry date was not re-ported), via an unspecified route of administration on 06Apr2021 13:35 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, fibromyalgia, intervertebral disc de-generation, post-traumatic stress disorder, back disorder all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; gabapentin (GABAPENTIN) taken for fibromyalgia, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia, post-traumatic stress disorder, start and stop date were not reported; naproxen (NAPROXEN) taken for back disorder, start and stop date were not reported. The patient previously 'Incurin' and 'Epitab' and experienced anaphylactic reaction. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that on 06Apr2021 at 13:35, patient had her second BNT162B2 vaccine. she ended up having an anaphylactic reaction was hospitalized and just got out today. She also want to say she have a history of having anaphylactic reaction from three different medication 'Incurin' and 'Epitab'. Patient stated that she had nothing wrong after the first one. Patient is a Nurse but not working right now. she was disabled (Further not clarified if consumer is physically disabled or financially) but she was a nurse. Patient was hospitalized on 06Apr2021. patient stated, she, was better. Her eyes are still swollen but she breathing when she went to hospital. Consumer stated for laboratory work Well in hospital they got lab, not before the vaccine and in the hospital they did lab when she got admitted in the hospital. Patient stated since she got in the hospital she have to take Prednisone for 5 days and Benadryl (treatment) for 5 days. she just got out of the hospital. The outcome of the event Anaphylactic reaction was recovering and for event eyes swollen was not recovered.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.
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| 55 | 2021-04-24 | taste impairment, oropharyngeal discomfort, dry mouth |
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ...
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felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
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| 55 | 2021-04-29 | mouth numbness |
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 1...
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Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
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| 55 | 2021-05-07 | mouth pain |
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/...
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Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
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| 56 | 2020-12-31 | lip swelling, tongue disorder |
Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores o...
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Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.
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| 56 | 2021-01-03 | toothache |
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was...
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After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
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| 56 | 2021-01-03 | taste impairment, mouth tingling | My tongue felt swelled and I had a metallic Taste in my moth |
| 56 | 2021-01-03 | mouth tingling, lip swelling |
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,...
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Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
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| 56 | 2021-01-04 | loss of smell, loss of taste |
Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable he...
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Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 23Dec2020 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020, the patient experienced loss of taste and smell, reported as non-serious. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the loss of taste and smell were not recovered.
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| 56 | 2021-01-05 | ear pain |
Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Rig...
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Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.
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| 56 | 2021-01-05 | mouth numbness |
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ...
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Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
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| 56 | 2021-01-05 | mouth numbness | Numb lips, tongue. Benadryl given |
| 56 | 2021-01-06 | mouth tingling, mouth discomfort |
Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and li...
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Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and lips approx. at 1010. Benadryl 25mg by mouth administered. Patient continued to be monitored for additional 1hr. Benadryl improved symptoms, patient denied SOB and remained calm throughout. Swelling and tingling improved. Patient went back to work in hospital where received vaccine. Patient confident in monitoring return of symptoms while on site working. Patient reports list of allergies and has dealt with symptoms of allergic reactions before. This RN checked on patient after vaccine clinic and residual tingling remained but otherwise patient "felt good". Called patient at 1707 to follow up. Patient reports minor residual burning on lip otherwise other symptoms resolved. Continues to denies difficulty breathing, " I feel fine"
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| 56 | 2021-01-06 | mouth numbness, feeling of choking, mouth tingling |
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ...
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Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
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| 56 | 2021-01-06 | inability to speak |
Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunc...
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Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.
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| 56 | 2021-01-06 | ringing in ears |
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/...
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Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | ringing in ears |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | mouth tingling |
Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red la...
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Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .
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| 56 | 2021-01-07 | tongue discomfort | 35 minutes After vaccination.... complaints of chest tightness, "funny" tongue |
| 56 | 2021-01-07 | loss of smell, loss of taste |
I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not t...
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I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.
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| 56 | 2021-01-08 | eye pain |
Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded ...
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Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded to Tylenol but returned as Tylenol wore off.
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| 56 | 2021-01-08 | taste impairment |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-10 | swollen tongue, mouth tingling |
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel...
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01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
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| 56 | 2021-01-10 | mouth pain | Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion |
| 56 | 2021-01-10 | bloodshot eyes, eye swelling, eye itchiness |
I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye ...
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I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye was puffy, swollen, red, itchy. I got a shot of dexamethazone and the next day I felt better. I also had a script for prednisone.
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| 56 | 2021-01-10 | mouth numbness | Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination |
| 56 | 2021-01-10 | mouth tingling |
Patient's reaction(s) noted during COVID vaccine observation period: lips tingling  Actions Taken:...
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Patient's reaction(s) noted during COVID vaccine observation period: lips tingling  Actions Taken: Vital signs taken and within normal for pt. Pt felt okay enough to leave  Disposition: Patient declined ED visit
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| 56 | 2021-01-10 | swelling of eyelid, eye itchiness |
The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids. ...
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The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids. She had a telehealth visit with doctor on 1/10/21 - she reported that the itchiness and swelling were along her upper eyelid near the brow line. Denied ocular pain, EOMI, conjunctive is not infected. Noted slight particles in the corners of her eye but it was not crusting. Had used hydrocortisone cream on the area but was advised by doctor to stop. Dr encouraged cold compresses, increased fluid intake and avoid salt/caffeine.
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| 56 | 2021-01-11 | mouth numbness |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | mouth numbness |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-11 | visual impairment |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | mouth itchiness, lip swelling |
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine dif...
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Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling. The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
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| 56 | 2021-01-11 | eye swelling | sudden onset nausea, malaise, fatigue, later that day developed eye swelling |
| 56 | 2021-01-12 | extreme sound sensitivity, sensitivity to light |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | ear pain | Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days |
| 56 | 2021-01-12 | ear pain, eye irritation, loss of smell, loss of taste | Congestion, loss of taste/smell, diarrhea, ear pain, eye irritation |
| 56 | 2021-01-12 | eye swelling |
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw...
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Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
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| 56 | 2021-01-12 | ear pain, eye irritation | exposure with ear pain , sore throat and eye irritation test negative |
| 56 | 2021-01-13 | thirst |
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t...
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"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
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| 56 | 2021-01-13 | eye pain |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | mouth tingling |
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ...
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Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
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| 56 | 2021-01-14 | mouth tingling |
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left...
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Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
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| 56 | 2021-01-14 | ringing in ears |
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
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| 56 | 2021-01-15 | extreme sound sensitivity, sensitivity to light, smell distorsion |
vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizzines...
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vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizziness); a heightened sense of taste, sensitivity to light, and increased startle reaction to sudden sounds
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| 56 | 2021-01-17 | swollen tongue, mouth tingling |
AFTER VACCINE PATIENT WAS COMPLAINING OF HER TONGUE AND THROAT FEELING A LITTLE TINGLY AND SWOLLEN. ...
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AFTER VACCINE PATIENT WAS COMPLAINING OF HER TONGUE AND THROAT FEELING A LITTLE TINGLY AND SWOLLEN. PATIENT DID NOT APPEAR TO BE IN ANY DISTRESS AT THE TIME BUT BASED ON HER COMPLAINT SHE WAS ADVISED TO HAVE THE AMBULANCE TRANSPORT HER TO THE HOSPITAL. IT TOOK ABOUT 20 MINUTES BUT AFTER TALKING TO HER FOR AWHILE AND FOUND OUT HER SON WAS AN RN I TOLD HER WE WOULD TRANSPORT HER THERE. SHE AGREED AND WAS TRANSPORT TO THE REQUESTED HOSPITAL. I SPOKE TO HER TONIGHT AT 9:40 PM AND SHE STATED SHE FELT FINE
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| 56 | 2021-01-17 | ear discomfort |
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow...
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Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
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| 56 | 2021-01-17 | mouth swelling | swelling of mouth |
| 56 | 2021-01-18 | taste impairment |
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour...
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10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
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| 56 | 2021-01-18 | mouth numbness |
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma...
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1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
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| 56 | 2021-01-18 | bloodshot eyes, vision blurred |
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ...
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Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-18 | mouth numbness, mouth tingling | itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache. |
| 56 | 2021-01-18 | mouth tingling | tingling tip of tongue and upper extremities |
| 56 | 2021-01-19 | mouth tingling, feeling of choking |
Approximately 25 minutes after receiving the vaccine I experienced tingling sensation of throat and ...
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Approximately 25 minutes after receiving the vaccine I experienced tingling sensation of throat and lips. Lips were not swollen. This lasted 40 minutes then resolved without any medication taken.
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| 56 | 2021-01-19 | taste impairment | Bitter taste and itching (General) Received Benadryl 50 mg and improved |
| 56 | 2021-01-19 | mouth tingling |
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ...
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Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
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| 56 | 2021-01-19 | loss of smell, loss of taste |
I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing...
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I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # not clarified, Expiry Date 30Apr2021) intramuscular at single dose in the deltoid on 08Jan2021 15:00 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified several drugs. On 08Jan2021 22:00, the patient experienced loss of taste, loss of smell, sneezing with outcome of unknown. No treatment required. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Jan2021. Nurse stated: "I just wanted to know the Covid Vaccine would it have given me that symptoms I mean obviously I'm exposed you know I do the testing at my office at school." When probed for causality, Nurse stated, "No, I don't think it would be from the vaccine, probably you know just exposure." Information on the lot/batch number has been requested.
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| 56 | 2021-01-19 | hearing loss |
My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am l...
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My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure. The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl? The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
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| 56 | 2021-01-19 | vision blurred |
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7...
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acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
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| 56 | 2021-01-20 | eye irritation | Severe fatigue, fever, chills, nausea, vomiting one time, head ache, eyes burning |
| 56 | 2021-01-21 | ear pain |
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea...
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Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
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| 56 | 2021-01-21 | lip swelling, mouth numbness |
Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and...
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Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and itching. I took Benadryl to help control symptoms.
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| 56 | 2021-01-24 | swelling around the eyes, lip swelling |
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ...
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face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
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| 56 | 2021-01-25 | taste impairment |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-26 | mouth tingling | Tingling in lips |
| 56 | 2021-01-26 | double vision, vision blurred |
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ...
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headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-27 | lip swelling, lip itchiness |
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app...
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Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
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| 56 | 2021-01-27 | eye swelling | I had facial swelling where my eyes were almost swollen shut and violent diarrhea. |
| 56 | 2021-01-27 | vision blurred, eye pain |
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ...
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On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
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| 56 | 2021-01-27 | oropharyngeal discomfort |
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizzines...
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Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
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| 56 | 2021-01-27 | taste impairment |
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil...
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metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
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| 56 | 2021-01-29 | lip swelling, swollen tongue |
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa...
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Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
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| 56 | 2021-01-30 | mouth tingling |
Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Be...
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Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Benadryl P.O. Discharged home with husband driving, advise to continue Bendaryl every 4-6 hours and to follow up with PCP.
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| 56 | 2021-01-31 | mouth numbness |
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p...
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Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
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| 56 | 2021-01-31 | swollen tongue, taste impairment |
Patient complained of metallic taste in mouth w/in 5 mins of vaccine on 1/22/21. On the next day, pa...
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Patient complained of metallic taste in mouth w/in 5 mins of vaccine on 1/22/21. On the next day, patient was biting tongue and felt was swollen, and took Benadryl. On 1/24/21, patient noticed tongue swollen and went to ER where was given prednisolone 60mg. Went to allergist 1/28/21 to perform allergy testing and was told allergic to the PEG (polyethylene glycol) and advised to defer dose #2.
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| 56 | 2021-01-31 | mouth tingling | tingling in tongue but especially with eating |
| 56 | 2021-02-01 | taste impairment |
After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After do...
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After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After dose #2-12 hours post injection, myalgias, chills and cough set in. Took to bed and became febrile @100.4, noted a metallic taste in mouth a/w headache. Lasting 48 hours.
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| 56 | 2021-02-01 | eye pain |
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa...
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Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
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| 56 | 2021-02-01 | ear pain |
fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, righ...
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fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, right ear ache, malaise
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| 56 | 2021-02-02 | ringing in ears |
Few Seconds of High Pitch Tinnitus night of vaccine - awoke with ongoing low level tinnitus that is ...
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Few Seconds of High Pitch Tinnitus night of vaccine - awoke with ongoing low level tinnitus that is not resolved
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| 56 | 2021-02-02 | loss of taste, loss of smell |
Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days...
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Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days I felt dizzy and I wake up to go to the restroom and I feel like I will fall. I treat with fluids .And I have an antiobiotics from appt with doctor. I had a little cough but not a bad one. My head hurts a little but not that much. COVID test on the 13th or so of January. Results on 16th - positive. They told me not to go to work. On the 30th I went to work.
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| 56 | 2021-02-02 | bloodshot eyes |
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 21:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced right side of her eye was completely blood shot. This morning 17Jan2021 there seems to be a raised vessel which is dark red in the same eye. The patient was not in pain, nothing scratching. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 56 | 2021-02-03 | loss of taste | Loss of taste 30 minutes after injection of my second dose. |
| 56 | 2021-02-05 | taste impairment | PATIENT EXPERIENCED A SALINE TASTE IN HER MOUTH, SHE REFUSED EXTENDED OBSERVATION. |
| 56 | 2021-02-06 | eye swelling |
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, sw...
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Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
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| 56 | 2021-02-07 | eye twitching |
Significant left eye twitching, with involuntary eye closure for a second, that occurred every 3-10 ...
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Significant left eye twitching, with involuntary eye closure for a second, that occurred every 3-10 minutes starting 2/5/21-2/8/21. Minimal occurrence on 2/8/21. Instructed to see hospital Ophthalmologist today.
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| 56 | 2021-02-07 | oropharyngeal discomfort |
Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short o...
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Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short of breath, something was going on in the back of my throat, heart rate went way up and I felt like I was going to pass out. About 09:10, I received an epi pen in my left thigh. After the epi pen, my symtoms resolved very quickly. I was then sent to the ED for a 4 hour observation. While in the ED, I received a unit of fluids. After which, I was discharged home.
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| 56 | 2021-02-07 | lip itchiness, mouth itchiness, swollen tongue, tongue itchiness, lip swelling |
my lips and tongue started itching and got swollen; my lips and tongue started itching and got swoll...
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my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-07 | swelling around the eyes |
within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next da...
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within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days; by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down along with pain in both knees which lasted another 2 days; I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
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| 56 | 2021-02-09 | visual impairment |
dizziness while lying in bed after turning over onto her back/ dizziness when standing up quick, tur...
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dizziness while lying in bed after turning over onto her back/ dizziness when standing up quick, turning over onto her back or side while in bed, and getting out of her car; had been a few times while lying in bed that her vision was affected when this dizziness comes on; This is a spontaneous report from a contactable consumer (reported for herself). A 56-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 07Jan2021 15:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypothyroidism, No Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included levothyroxine. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine was given on a Thursday afternoon, on Saturday morning, the patient experienced a dizziness while lying in bed after turning over onto her back. She only experienced the dizziness when standing up quick, turning over onto her back or side while in bed, and getting out of her car. She had never had any trouble with dizziness. There had been a few times while lying in bed that her vision was affected when this dizziness comes on. To date she was still having problems. The events started on 09Jan2021 06:30. No any treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
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| 56 | 2021-02-09 | mouth tingling, feeling of choking |
tingling sensation in throat and lips; tingling sensation in throat and lips; This is a spontaneous ...
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tingling sensation in throat and lips; tingling sensation in throat and lips; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL0142, via an unspecified route of administration on 12Jan2021 09:30 at single dose at left arm for covid-19 immunisation. Medical history included Grave's Disease, Lobular carcinoma of breast (LCIS), allergies: sometimes reddened skin from tape/bandaid. Concomitant medications included levothyroxine sodium (SYNTHROID), tamoxifen and vitamin D3. The patient experienced tingling sensation in throat and lips on 12Jan2021 09:45 AM. It was also reported that tingling sensation in throat and lips approximately 25 minutes after vaccine given, lasted approximately 40 minutes and resolved completely on 12Jan2021 with no medications to treat it.The patient was not pregnant. No other vaccine received in four weeks. If COVID prior vaccination: No. If COVID tested post vaccination: No.
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| 56 | 2021-02-09 | ear pain |
vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nau...
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vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 56 | 2021-02-14 | eye swelling |
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res...
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1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
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| 56 | 2021-02-14 | smell distorsion |
After first dose severe headache for two days with some dizziness. After second dose sleepless that...
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After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
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| 56 | 2021-02-14 | swollen tongue, thirst | Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst |
| 56 | 2021-02-14 | mouth tingling |
Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the...
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Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the vaccine. Vital signs initiall BP 178/92, HR 98, spo2 98%. Denied shortness of breath or other symptoms at that time. Patient took benadryl 25 mg PO, after about 10 minutes verbalized tingling of her tongue. No further progression of symptoms. 911 called & patient sent to ED for evaluation in stable condition. Medical staff
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| 56 | 2021-02-15 | loss of smell, loss of taste | fever; severe chills; diarrhea; vomiting; loss of taste and smell; extreme fatigue |
| 56 | 2021-02-16 | ringing in ears |
tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a l...
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tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-18 | eye pain, ringing in ears |
Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and ...
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Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
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| 56 | 2021-02-20 | taste impairment |
Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea,...
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Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting
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| 56 | 2021-02-21 | sensitivity to light, ringing in ears, extreme sound sensitivity |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-22 | swelling of eyelid, eye swelling | Swelling of eyelid and around the eye |
| 56 | 2021-02-23 | ear pain, eye swelling |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-24 | swollen tongue | Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats |
| 56 | 2021-02-24 | pain in jaw |
Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I wo...
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Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I would deep breath to calm down. Took my Pulse/O2 and it was 98% and 62BPM and BP was 107/58 that day (6 Feb). Took it the next day and we had a 98% and BPM of 58 and BP went to 148/72 ( very unusual for me). 4 days later took Pulse/O2 at 98% 58BPM and BP at 120/62. I feel pain in the center of my chest where my heart is and I have never had this in my life until 2 days after the vaccination. I am now taking a lung support (Clear Lungs - Nutritional Therapeutics) in case I have a lung issue. I live at 5000' and can walk and I now only do light exercise so I don't feel the heaviness or "stress" feeling in my heart. I have not gone to the dr yet. On 8 Feb my chest was really hurting and did feel some pain on my lower jaw and this went on for about 2 hrs. I did not go to the hospital. Something is wrong since getting this shot even though the symptoms are subsiding. Again, for someone without comorbidities or a history of her heart ever hurting to have this happen 1 1/2 days after the vaccine is not a coincidence and from all data that can be found this is an anomaly. I am troubled and concerned about my reaction.
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| 56 | 2021-02-25 | vision blurred |
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ...
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15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
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| 56 | 2021-02-25 | ringing in ears, hearing loss |
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As...
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Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
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| 56 | 2021-03-01 | lacrimation increased, eye pain, bloodshot eyes |
On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye ...
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On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye and growing pain in eye itself. Eye was watering and red and very painful. Symptoms persisted. On February 24, patient went to Urgent Care who found ulcerations on cornea and referred to ophthalmologist, Dr., who suspected herpes sores, perhaps due to an immune system reaction to the second Covid shot. Treated with eye drops (Moxifloxacin, 0.5% 4 times daily), and oral antiviral (Valaclyclovir HCL, 500 mg 2 tablets three times daily). Eye is MUCH improved, but the ulceration has not entirely disappeared. It is to be hoped that completing the Moxifloxacin and Valclyclavir regimen will completely clear the damage, but there is some concern that there may be permanent scarring. A fourth examination is scheduled for March 10.
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| 56 | 2021-03-01 | mouth numbness |
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke o...
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On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire. It quickly spread over entire body. I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb. PCP office told me to hang up and go to the nearest emergency room.
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| 56 | 2021-03-02 | taste disorder |
After getting the vaccine and driving home, one side of my face started to feel like it was getting ...
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After getting the vaccine and driving home, one side of my face started to feel like it was getting a little numb. It has stayed the same all day and has not gotten worse. There has been no facial drooping. Also, I have had a metal taste in my mouth.
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| 56 | 2021-03-03 | mouth tingling |
Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding with...
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Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding within minutes of shot. That lasted into 2nd day. Lots of dizziness, nausea & headache into day 2
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| 56 | 2021-03-03 | mouth numbness |
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes...
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swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
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| 56 | 2021-03-04 | eye swelling |
pt described doing fine during initial observation period. She went grocery shopping and within abou...
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pt described doing fine during initial observation period. She went grocery shopping and within about 3 hours of receiving the vaccine, her eyes swelled "like bugged out" and she had her blood pressure taken at home with a systolic measurement of 214. Someone else in her home checked the functioning of the B/P cuff and theirs measured normally. The patient rechecked hers at that point and it was 200+. She does not had a history of hypertension and has never been on anti-hypertensives.
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| 56 | 2021-03-06 | tongue disorder, dry mouth |
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa...
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Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
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| 56 | 2021-03-06 | eye swelling |
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after...
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Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn.. Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head. Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related to Covid Vaccine and to report it to VAERS. As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
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| 56 | 2021-03-08 | dry mouth, mouth numbness, mouth tingling, feeling of choking |
I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I wok...
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I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I woke up several times with 'cotton mouth' and a strange feeling that the back of my mouth, roof of my mouth and maybe a bit of my throat had a numb and tingly feeling. I drank quite a bit of water, but kept falling back to sleep. I can only compare it to when you receive novacane at the dentist but the sensation starts to goes beyond your mouth and a bit into your throat. This feeling stayed about the same for 3 hours and then over the next 3 hours started to dissipate. After that I just hand a mild lingering headache and general feeling of tiredness. By the next morning I just had a slight headache and physical feeling of tiredness.
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| 56 | 2021-03-08 | bloodshot eyes, eye itchiness |
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm...
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On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
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| 56 | 2021-03-08 | ear pain |
Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigu...
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Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigue
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| 56 | 2021-03-08 | lacrimation increased |
was speaking to patient as she has had hx of anaphylaxis to sulfa medication. she was fine speaking ...
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was speaking to patient as she has had hx of anaphylaxis to sulfa medication. she was fine speaking to me and 9mins after vaccine developed blank stare eyes became watery and told me she needed Benadryl she didn't feel well. asked her what she felt and her response was delayed and stated "throat felt like it was closing: trouble breathing. Called a code and told RN to get me epi 0.3mg which was administer to opposite arm (right upper arm) . brought patient to the floor and kept legs elevated. Benadryl 50mg IM given to Left deltoid. unable to get BP as the machine was not giving me BP :manual cuff to small. code team responded within 5mins. EKG leads placed on patient showing sinus tach 140 O2 sat 99% .. patient continued to be responsive and once epi was given spoke more requesting husband.. patient was put on stretcher and taken to ED by code team.
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| 56 | 2021-03-09 | taste impairment | had immediate strong metallic taste in mouth |
| 56 | 2021-03-10 | blindness, visual impairment, vision blurred, dry mouth, thirst |
The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxie...
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The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty. The second vaccine EN 6201 I had a headache the next day. Throbbing headache. I read not to take Advil or anything right after. February 09= vaccine February 10=headache February 11= headache didn't go away. I took Advil in the evening. February 12=headache worsened. I took Advil in the afternoon. February 13=I woke up and couldn't see out of my left eye. There was a fog in central vision. About an hour later there was a strange aura. A tornado like tunnel in the central vision started and then shot out from the corner of my left eye. The aura lasted seconds and then the foggy center dissipated throughout the day. The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day. February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit. Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary. My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine. Maybe the headache and the Ocular Migraine was caused by the vaccine. Who knows. I just thought I would report it in case other people have the same. Collecting data is a good thing.
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| 56 | 2021-03-11 | deafness unilateral | Loss of hearing in right ear. After hearing test completely deaf in right ear. |
| 56 | 2021-03-11 | swollen tongue, mouth tingling |
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h...
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Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
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| 56 | 2021-03-12 | bloodshot eyes, eye bleeding |
At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/...
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At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/12/21, Friday afternoon around 2:30pm, I noticed my left eye didn't feel right. I looked in the mirror and my left eye was slightly red in the corner of my eye towards my nose. When I woke up this morning on 3/13/21, my eye was completely red in that same corner of my left eye. I went to the a walk-in clinic this morning to have it checked out. The doctor indicated that it was a burst blood vessel in my eye and that the redness should go away in about a week. My BP was 148/100. The doctor asked if I had a history of high blood pressure and I told him no and showed him 3 of my previous BP card records that I keep in my purse. He said I should monitor my blood pressure and follow up with my primary care doctor. I have had a blood vessel burst in my eye before a few years back. I do not remember which eye. I have had fibromyalgia for over 20 years. I was diagnosed with Occular Myesthenia Gravis in January 2017 which affects my left eye only.
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| 56 | 2021-03-13 | ringing in ears |
Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored br...
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Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored breathing around 30 minutes post-dose but fine after using inhaler (may have been due to wearing multiple masks vs. vaccine; tension, dull headaches starting 1hr post-dose lasting several hrs; high-pitching ringing in ears starting approx 7-8 hrs post-dose and still have as of March 14 at 5:00pm; systemic itching starting 8-9 hrs post-dose and still have as March 14 at 5:00pm and managing with Benadryl/zyrtec. Alerted Dr. to ringing in ears and following up with Dr tomorrow on ringing in ears and itching.
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| 56 | 2021-03-14 | mouth discomfort, eye irritation |
woke up with my mouth on fire like it had been dipped in jalapeno oil; Eyes then started to burn sa...
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woke up with my mouth on fire like it had been dipped in jalapeno oil; Eyes then started to burn same way; This is a spontaneous report from a contactable Health care professional (Patient). A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 03Feb2021 09:30 at SINGLE DOSE for covid-19 immunisation. Facility where the COVID-19 vaccine was administered: Nursing Home. The patient's medical history included Antiphospholipid antibody syndrome, arthritis, allergic to Sulpha. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included warfarin, eplerenone, furosemide, oxycodone hydrochloride. On 04Feb2021 02:00, the patient reported that, I felt fine, went to bed, woke up with my mouth on fire like it had been dipped in jalapeno oil. Eyes then started to burn same way. Called advice nurse, she recommended benadryl. Followed up with pcp at noon next day. Advised against 2nd shot. The patient has received treatment with antihistamine. Outcome of the events were not recovered. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 56 | 2021-03-15 | taste impairment |
Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle ...
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Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle and knee soreness, headache, very sore left arm, flu-like -ache in nipples Arm soreness declined over two weeks, ankle and knee soreness currently persist, fatigue lasted one week, other symptoms stopped after third or fourth day Treatment was acetaminophen, increased water intake and rest
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| 56 | 2021-03-15 | ringing in ears, deafness | Sudden hearing loss/tinnitus in right ear. |
| 56 | 2021-03-15 | mouth tingling |
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and g...
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flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
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| 56 | 2021-03-16 | dry mouth, mouth numbness |
Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minut...
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Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minutes after administration of vaccine. Normal SpO2 97%. BP initially slightly elevated 147/87, repeat 126/72. RR 20, HR 91. No wheeze, stridor or difficulty breathing. Dry mouth reported, no swallowing difficulty. Patient calm, no diaphoresis or pallor. Skin warm and dry. EKG (3 lead) with normal sinus rhythm, occasional premature ventricular contractions, no significant ST/T wave changes. Symptoms of chest pressure resolved spontaneously within 30-45 minutes with monitoring, no treatment required. Lip numbness significantly improved, minimal upper lip sensation changes persisted . No swelling of lips or tongue or throat. Patient never experienced tachypnea, tachycardia or diaphoresis. Patient declined ER transport via EMS. Precautions discussed - if persisting or recurring symptoms, encouraged patient to call 911 or contact PCP.
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| 56 | 2021-03-17 | ringing in ears |
Approximately 30 minutes after my injection I experienced tinnitus. It is very loud and has not stop...
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Approximately 30 minutes after my injection I experienced tinnitus. It is very loud and has not stopped since the vaccine.
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| 56 | 2021-03-17 | mouth numbness |
Client received the 1st dose of Pfizer Covid vaccine (Lot #ER 2613, Exp. 7/2021). Client was sitting...
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Client received the 1st dose of Pfizer Covid vaccine (Lot #ER 2613, Exp. 7/2021). Client was sitting on post-vaccine waiting area approximately 10 minutes and alerted EMT at 1408 of numb sensation on tongue. PHN joined EMT to further assess client. Client alert and oriented, stated numb sensation at mid top of tongue. Sensation not radiating anywhere else. Vitals at 1411: Pulse 87, blood pressure 176/108, oxygen 99, respirations 22. Minor headache per client on left side. Client denied tingling sensation, dizziness, shortness of breath, chest pain. PHN assessed for swelling around face and inside mouth. 1417 PHN reassessed blood pressure and obtained 172/102, pulse 80. Client stated history of brain aneurysm 2yrs ago, brain tumor, diabetes, and hypertension. No history of allergies. Per client takes metoprolol in the evenings and yesterday's last reading 113/67. Per client blood pressure has been controlled and follows up with provider. Medication she currently takes: metformin, multivitamins, and metroprolol. PHN informed client due to medical history and high blood pressure it was recommended to be further assessed at the hospital. Client agreed, PHN called 911 at 1423. Client's daughter waiting in car, client called her to update her. Paramedics assumed care at 1426. Client transported to Hospital.
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| 56 | 2021-03-17 | mouth numbness, mouth tingling |
Patient spent 15 min in observation and left the site, but came back shortly complaining of numbnes...
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Patient spent 15 min in observation and left the site, but came back shortly complaining of numbness and tingling in the mouth and tongue . Vitals assessed, within normal limits, liquid benadryl 12.5 MG administered. Patient Vitals within normal limits x3 every 10 min. After 30 min Patient states numbness significantly improved. Patient left site with partner and educated to call 911 for any severe side effects and to reach out to hcp regarding incident.
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| 56 | 2021-03-17 | swollen tongue, mouth tingling, tongue discomfort | Swollen tongue, lips tingling, tongue felt "burnt" |
| 56 | 2021-03-18 | swollen tongue |
30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with f...
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30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with facial and tongue swelling and difficulty swallowing. A rapid response was called and the patient was taken to the emergency department where she had an IV placed and received IV famotidine, IV diphenhydramine, IV methylprednisone, a NS bolus, and epinephrine. Patient was then monitored in the ED. Patient has plans to discharge from the ED to home. COVID vaccine was placed as an allergy in the patient chart.
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| 56 | 2021-03-18 | lip swelling | Swollen lip and chin about 12 hours after vaccine; doctor has advised to try Tylenol PM |
| 56 | 2021-03-20 | swollen tongue, mouth numbness | Swollen tongue, diarrhea, throat closing, numb tongue, numbness on left cheek on face. |
| 56 | 2021-03-20 | taste impairment |
metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-...
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metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration on left arm on 03Feb2021,15:45 at single dose for COVD-19 immunization. The patient medical history included High blood pressure, Allergies: Raw Eggs. Concomitant medication included hydrochlorothiazide taken; verapamil; biotin, calcium pantothenate, chromic chloride, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide (CENTRUM VITAMINTS). The patient previously took prednisone, metoprolol, lisinopril, losartan and all had Allerges. No Covid prior vaccination and no Covid tested post vaccination. It was reported that, the patient experienced metallic taste in mouth on an unspecified date in 2021. The outcome of the event was reported as recovered on 2021.
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| 56 | 2021-03-23 | oropharyngeal discomfort |
Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of ...
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Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of incident: vaccine hub triage area Pertinent patient history: History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine. Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED. Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN Patient outcome: Transported via EMS to ED Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033. Other notes: Other RN's involved in this event were RN, RN, RN, Dr., and Dr. RN .................... 3/24/2021 11:04 AM
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| 56 | 2021-03-23 | swollen tongue |
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s...
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Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
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| 56 | 2021-03-23 | vision blurred |
Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my ey...
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Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my eyes are little bit weaker; seems like my eyes are little bit weaker; Heart feels like racing; This 56- year-old female consumer (patient) reported for herself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6201 ), via an unspecified route of administration, on 20Feb2021 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "I had my second shot of Pfizer vaccine yesterday (20 Feb 2021), today, I suffered being tired. I put on my glasses to watch movie and screen looks fuzzy. It seems like my eyes are little bit weaker or something. My heart feels like racing. I don't think it is racing but it feels like it is. I was wondering if there is any side effects like slightly less accurate vision." The outcome of the events looks tired, fuzzy, eyes weaker, and heart feels racing was unknown.
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| 56 | 2021-03-23 | lip swelling, mouth tingling, mouth discomfort, mouth numbness |
Woke with a swollen bottom lip on day 8 post injection. Day 9 same swelling but additional numbness...
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Woke with a swollen bottom lip on day 8 post injection. Day 9 same swelling but additional numbness and uncomfortable feeling. Day 10, still swollen and some numbness and upper lip is now tingling and slightly swollen.
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| 56 | 2021-03-24 | taste impairment, swollen tongue |
About 30 minutes after the injection, my throat felt tight like it was closing up. Then I started to...
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About 30 minutes after the injection, my throat felt tight like it was closing up. Then I started to have a funny taste, almost like metal in my mouth and my tongue started to fatter as though it was swelling. I never lost the ability to breath but felt a little constricted in my throat. The "puffy tongue side effect lasted for about 15 minutes and drinking water seemed to help. The throat constriction went away after about 5 minutes. We were already away from the vaccine site so we did not see any health professional for these symptoms but would have if they did not go away.
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| 56 | 2021-03-24 | eye itchiness, swelling of eyelid |
Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hand...
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Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hands and feet, sneezing, runny nose Took 1 25mg Benadryl tablet within 5 minutes of start of symptoms, had to take another 25mg Benadryl tablet approximately 30 minutes later because eyes were continuing to swell and itch Also experienced onset of severe headache about 45 minutes after shot Went to bed and slept for 3 hours after taking the second Benadryl. Felt better after waking, still had slight swelling in eyelids. Experienced minor itching at 10:30 pm, took 2 more Benadryl tablets at 11 pm. Minor eyelid swelling next morning, minimal itching.
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| 56 | 2021-03-24 | visual impairment |
Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingli...
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Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it. I moved it around until it finally stopped. Pain continued all not. On 3/24/21 was very tired and foggy. On 3/25/21 have a headache and slight nausea. I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine. I am fine just thought I should report these occurred. Thanks!
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| 56 | 2021-03-25 | bloodshot eyes, eye swelling |
About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as...
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About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as shot). It was improving then 2 weeks after second shot in other (right) arm it flared back up and worsened significantly. Bright red, itchy painful rash all over neck, red swollen eyes, rash patches on face, down arms and hands. Treated with antihistamines and cortisone ointment. Overall rash symptoms lasted about 6 weeks, while worst symptoms lasted several days. While not formally diagnosed with covid, I believe I had it Jan-March 2020 and the final symptom was a very similar rash on my neck. These are the only 2 times I have ever had such a rash. I have photos to share of you want to see them.
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| 56 | 2021-03-25 | mouth tingling |
About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left...
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About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left side only, started tingling. My tongue felt fat but didn?t appear fat. However, I slurred about six words. Then one tip of finger started tingling. I had no other symptoms. I immediately took one child Benadryl pill (half an adult dose). I had an epi-pen ready but didn?t need it (I?ve never had anaphylactic reaction before, but my throat has tightened from malic acid before, so I wanted to be prepared). I went home and slept rest of afternoon, probably because of the Benadryl. I had no respiratory issues; no hives; throat did not swell. Just lip tingling, ?fat? feeling tongue, and finger tip tingling.
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| 56 | 2021-03-25 | loss of smell, loss of taste | Loos of taste and smell |
| 56 | 2021-03-25 | mouth itchiness |
Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she ...
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Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she didn't have any allergic reaction to another vaccine or to an injectable medication but she has allergy to sunflower, flaxseed, and latex. So she received Pfizer vaccine. 9 minutes after the vaccine, patient started to feel itchiness on her face especially around the nose and mouth, then she felt it going down to her chest. Vaccinating pharmacist noticed that the patient was getting redness around patient's neck, she called other pharmacist and they both went to talk to the patient. When patient was asked about symptoms that she was feeling, patient mentioned that it was the itching that bothered her the most. She denied that she has difficulty breathing or dizziness. So I drew up 1 mL of diphenhydramine and injected it IM to the other arm. Pharmacist watched her for another 20 minutes in the room. Patient kept complaining about the itchness but no other symptoms. Patient called her husband to come and pick her up. Patient was instructed to take benadryl at home if symptoms persist. And patient was also instructed to see medical help if symptoms were getting worse. Husband came and picked up the patient and patient went home
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| 56 | 2021-03-26 | ear discomfort |
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch...
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March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
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| 56 | 2021-03-27 | swollen tongue, visual impairment |
Swollen tongue with lesion, extreme fatigue, muscle aches, vision disturbances, stomach issues, elev...
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Swollen tongue with lesion, extreme fatigue, muscle aches, vision disturbances, stomach issues, elevated liver enzymes
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| 56 | 2021-03-27 | swollen tongue |
Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck....
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Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck. I took half of a Zytec antihistamine, one Advil and drank extra water. Applied an ice pack. Stiff neck stopped at 36 hours. Swollen tongue stopped at 48 hours. Left cheek swelling went down by 50 % at 72 hours.
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| 56 | 2021-03-28 | ringing in ears |
Inability to lift arm (muscles in left upper arm became very painful and could not be lifted more th...
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Inability to lift arm (muscles in left upper arm became very painful and could not be lifted more than a few inches from my side, problem began about 4 hours after injection and lasted approximately 24 hours). Tinnitus (ringing in both ears increased steadily each day after injection, ringing reached a peak at approximately 1 week after injection and still persists)
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| 56 | 2021-03-29 | swollen tongue, eye swelling |
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac...
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The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
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| 56 | 2021-03-31 | mouth numbness, lip swelling |
angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a cont...
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angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-04-07 | taste impairment |
Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from...
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Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 24Mar2021 at 10:45 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included clopidogrel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 minutes after injection (24Mar2021 at 11:15 AM), the patient felt throat tighten up and tongue started to enlarge. Also, the patient had strange metal taste but never lost ability to breathe. After drinking some water and about 15 minutes, the symptoms went away. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Mar2021 at 11:30 AM.
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| 56 | 2021-04-08 | eye swelling, lip swelling |
Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling fac...
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Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration on 17Mar2021 06:00 PM as single dose in right arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included idiopathic angioedema and no chronic health conditions. Patient had allergies to medications, food, or other products included Zithromax - anaphylactic, several other antibiotic - rash, hornet and wasp sting allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 at 10:00 AM, the patient experienced angioedema - swelling face, eyes, lips and throat which occurred 16 hours after injection. Event resolved with use of Benadryl. Prior history of angioedema. Since symptoms resolved with Benadryl, I did not seek further medical care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events were recovered in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-04-12 | visual impairment |
Pt reported to the ER two days after vaccination on 03/12/21 with complaints of visual difficulties ...
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Pt reported to the ER two days after vaccination on 03/12/21 with complaints of visual difficulties and gaze abnormalities. Stroke code was activated at 1445. After CT, pt was flown to Hospital for work up by neurology. Underwent CTA, throbus in right PCA. Underwent thrombectomy. Complications from stroke and difficult airway led to intubation and mechanical intervention, extubated the next day. Pt discharged from hospital 03/17 on Eliquis.
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| 56 | 2021-04-12 | smell distorsion, taste disorder |
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s...
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elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
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| 56 | 2021-04-13 | ringing in ears | Tinnitis, began the day after the vaccine and has not abated. High-pitched ringing in the ears. |
| 56 | 2021-04-15 | ringing in ears | Tinnitus |
| 56 | 2021-04-17 | eye bleeding |
one eye is red like it has vessels like broken or bleeding in there; This is a spontaneous report re...
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one eye is red like it has vessels like broken or bleeding in there; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was feeling ok and everything, but one eye was red like it had vessels like broken or bleeding in there on 02Apr2021, she said it didn't hurt. The outcome of event was unknown. Information on the lot/batch number has been requested.
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| 56 | 2021-04-18 | ringing in ears |
The onset of symptoms began 10 hours after the second dose injection, including severe headache, fev...
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The onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift -- with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. No prior history of tinnitus or auditory disorder.
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| 56 | 2021-04-18 | double vision |
Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spont...
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Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm. On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
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| 56 | 2021-04-20 | vision blurred |
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L...
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Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
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| 56 | 2021-04-24 | taste disorder |
tightening sensation in throat air way restricting; tightening sensation in throat air way restricti...
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tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
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| 56 | 2021-04-30 | ear pain, eye discomfort |
only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain...
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only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.
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| 56 | 2021-05-03 | ringing in ears |
Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable...
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Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 AM (at 56-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: Sulfa drugs. No prior history of tinnitus or auditory disorder. No covid prior vaccination. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 AM (at 56-year-old) at single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. On 10Apr2021 07:00 PM, the onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. The events resulted in disability or permanent damage. No treatment was received for the events. The outcome of the events was not recovered. No Covid tested post vaccination.
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| 56 | 2021-05-04 | pain in jaw, ear pain |
Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spon...
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Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation. Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
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| 56 | 2021-05-07 | vision blurred |
faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fev...
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faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry, start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-05-10 | deafness unilateral |
Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). ...
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Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eng199), via an unspecified route of administration, in left arm on 24Mar2021 09:00 (at the age of 56-years-old) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant at the time of vaccination. Patient received vaccine at the Pharmacy or Drug Store. The patient experienced complete deafness in right ear on 11Apr2021. Hearing loss was not regained with current aggressive medical care. The event resulted in physician or other healthcare professional office or clinic visit and considered as serious due to disability. Since the vaccination, patient has not been tested for COVID-19. The patient was treated with steroids, several other medications and oxygen. Outcome of the event was not resolved.
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| 56 | 2021-05-10 | vision blurred |
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache...
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anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
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| 56 | 2021-05-10 | ear discomfort |
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ...
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she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-02 | mouth tingling |
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ...
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Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
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| 57 | 2021-01-03 | eye pain, sensitivity to light, eye irritation, visual impairment, vision blurred, lacrimation increased |
Took covid shot Thursday 12/17. On Friday 12/18 had avastin shot to right eye. That afternoon had EX...
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Took covid shot Thursday 12/17. On Friday 12/18 had avastin shot to right eye. That afternoon had EXTREME inflammation, irritation, tearing, pain and light sensitivity. Vision became "whited out". Saw Dr. sunday 12/20, received two antibiotic shot and steroid shot all to right eye. Prescribed Levaquin po and antibiotic and steroid eye drops. Followed up with retinologist again today 1/4/21, symptoms fairly resolved but vision is still blurry. Hoping to completely regain my sight.
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| 57 | 2021-01-03 | taste disorder |
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach...
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right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
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| 57 | 2021-01-04 | ear pain |
I had most of side effects described. My ears hurt, like inside, but the most that bothers me today ...
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I had most of side effects described. My ears hurt, like inside, but the most that bothers me today is that my heart feels like its beating and racing fast, sometimes feels like its pounding. Very uncomfortable, my chest feels.
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| 57 | 2021-01-04 | sensitivity to light |
Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diar...
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Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.
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| 57 | 2021-01-04 | ringing in ears |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-04 | bloodshot eyes, eye itchiness |
allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and i...
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allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
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| 57 | 2021-01-04 | smell distorsion, taste disorder |
cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebr...
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cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
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| 57 | 2021-01-04 | taste impairment |
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs...
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metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 57 | 2021-01-05 | ear pain |
10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes wh...
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10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation. Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
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| 57 | 2021-01-05 | mouth tingling |
10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, dev...
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10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports "feeling great" this a.m.
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| 57 | 2021-01-05 | lip swelling |
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov...
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Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
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| 57 | 2021-01-05 | taste impairment |
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at les...
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Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
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| 57 | 2021-01-05 | swollen tongue |
Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. gi...
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Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. given IM Benadryl and symptoms resolved. Previous similar reaction to crab.
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| 57 | 2021-01-05 | eye pain |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | bloodshot eyes |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted ge...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted general pruritus without rash, mild scleral injection. No other systemic symptoms. Pt treated with Benadryl 25mg x1. Symptoms resolved within 30-45 minutes.
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| 57 | 2021-01-06 | loss of smell, loss of taste |
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever w...
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I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
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| 57 | 2021-01-06 | oropharyngeal discomfort |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-07 | pain in jaw |
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: R...
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Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care
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| 57 | 2021-01-07 | mouth tingling | Mouth and lips tingling |
| 57 | 2021-01-07 | mouth tingling, lip swelling |
Patient experienced lower lip swelling and tingling. Patient given 12.5 mg of Benadryl and monitore...
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Patient experienced lower lip swelling and tingling. Patient given 12.5 mg of Benadryl and monitored for 30 minutes. Symptoms resolved.
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| 57 | 2021-01-07 | mouth tingling |
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ...
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Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
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| 57 | 2021-01-08 | mouth tingling |
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all...
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2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
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| 57 | 2021-01-08 | deafness, ringing in ears |
I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, ...
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I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.
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| 57 | 2021-01-08 | ringing in ears | Ringing in ears |
| 57 | 2021-01-10 | vision blurred |
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev...
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experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 57 | 2021-01-10 | vision blurred |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-11 | double vision | DOUBLE VISION STARTED 24HR FOLLOWING VACCINE |
| 57 | 2021-01-11 | loss of smell, loss of taste | Loss of taste/smell, sore throat, chills. Positive swab for Covid 12/29/20 |
| 57 | 2021-01-11 | taste disorder | STRANGE TASTE IN MOUTH RIGHT AFTER INJECTION |
| 57 | 2021-01-11 | swollen tongue |
Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to...
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Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to ER with complaints of sensation of ?foreign body? in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Treatment: Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition.
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| 57 | 2021-01-11 | mouth tingling |
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a...
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pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
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| 57 | 2021-01-12 | vision blurred |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-12 | dry eye |
Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre...
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Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre-diabetes, and osteoporosis s/p recent fibular fracture who presents for facial weakness. Patient is a research MD in the neurology department. Patient reports that she woke up this morning with weakness of the right face and inability to close the right eye. She reports mild discomfort in the area of her right jaw, but no ear pain. Denies any change in hearing or taste. She denies any difficulty chewing or swallowing, but has noticed that water will come out the side of her mouth when she tries to drink. She reports mild dry eye on the right. No history of similar symptoms. Today is day 18 after her first COVID vaccination. No recent URI symptoms. No unilateral numbness or weakness. No autoimmune history.
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| 57 | 2021-01-13 | eye irritation |
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th...
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Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 57 | 2021-01-13 | loss of taste, loss of smell |
COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID v...
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COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
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| 57 | 2021-01-13 | eye disorder |
Pfizer-BioNTech COVID-19 At about 7:30 pm, approx 7-8 hour post injection, I had some jaw tightness ...
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Pfizer-BioNTech COVID-19 At about 7:30 pm, approx 7-8 hour post injection, I had some jaw tightness and began to see flashing lights out of the left side of my left eye. They were still present when I awoke at 5:30-6:00 am on Tuesday.
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| 57 | 2021-01-13 | lip swelling, mouth tingling, eye swelling |
THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT W...
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THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT WASN'T UNTIL THE PATIENT WAS HOME, ABOUT 11 HOURS POST VACCINATION, THAT THEY REPORTED SWELLING & ITCHINESS AT THE INJECTION SITE, SWOLLEN, TINGLY LIPS AND SWELLING UNDER THE EYES. THE PATIENT REPORTED TAKING BENADRYL, WHICH EFFECTIVELY RESOLVED THE REPORTED SIGNS & SYMPTOMS.
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| 57 | 2021-01-13 | tunnel vision |
Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilli...
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Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilling and could not get warm. Fever reached 101 degrees. I took 2 Tylenol every 4 hours. While I had a fever, I could not seem to drink enough water. I consumed about 90 ounces of water from 2pm til 9pm. The fever and chills became less prevalent by 9pm. Continued the Tylenol through 7AM the morning of 1/12/21. My chills were gone and I had no fever by then.
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| 57 | 2021-01-13 | taste impairment |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-13 | mouth tingling |
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g...
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tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
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| 57 | 2021-01-14 | taste impairment, tongue disorder |
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth...
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20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
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| 57 | 2021-01-14 | lacrimation increased | Dizziness, Body ache Teary eyes pain to right arm Headache |
| 57 | 2021-01-15 | visual impairment | Debilitating dizziness and vision impairment |
| 57 | 2021-01-15 | visual impairment, bloodshot eyes |
On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started havin...
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On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started having visual disturbances. The next morning 12/23/2020 I woke up with a bloody eye it was my right eye it lasted one day. On the following Monday on 12/28/2020 I was not feeling good I started getting headaches, feeling aching, at night I started getting fevers, congestion, & fatigue. It went away on 1/1/2020. Seen doctor on 12/29/2020
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| 57 | 2021-01-16 | mouth tingling, eye pain |
I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose to...
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I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose today and about 40 minutes after dose I had some tingling in lips, and then left sided facial pain, along cheek behind eye. hurts to smile and use that side of face. have taken a Benadryl I haven't read about this as a side effect. With the first dose this did resolved after 24 hours
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| 57 | 2021-01-17 | dry eye |
Vertigo, eye drooping, tenderness to head, pressure in head, inflammation of the head, neck and shou...
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Vertigo, eye drooping, tenderness to head, pressure in head, inflammation of the head, neck and shoulders. Has been to PCP x 3. Scheduled for MRI 01/23/2021
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| 57 | 2021-01-17 | mouth pain | sore mouth and tongue was stiff and extreme fatigue feels tired even a week later |
| 57 | 2021-01-18 | oropharyngeal discomfort |
Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. W...
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Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. Was treated with a single dose of Dexamethasone 10 mg IV. Symptoms resolved and patient was sent home.
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| 57 | 2021-01-21 | ear pain |
1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fe...
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1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fever. 2 pm temp 100.8, bilateral ear drum pain 1/16/21 8 am fatigue. 1/17/21 2am woke up with chills nausea and ear pain. 1/17 in morning fatigue . 1/18/21 asymptomatic.
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| 57 | 2021-01-21 | dry throat |
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri...
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Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
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| 57 | 2021-01-21 | ringing in ears |
Received vaccine at 13:45 on 1/19. Awoke around 04:00 on 1/20 with loud ringing/buzzing in ears. The...
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Received vaccine at 13:45 on 1/19. Awoke around 04:00 on 1/20 with loud ringing/buzzing in ears. The intensity continued until approximately 07:00 1/21. I still have low buzzing sound/ tinnitus. I had the day off work but probably could not have worked (as a pharmacist) if I hadn?t. I returned to work on 1/21 though. I have a hearing test on 1/28.
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| 57 | 2021-01-21 | loss of smell, eye pain, loss of taste, sensitivity to light |
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/...
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received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
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| 57 | 2021-01-24 | eye discomfort |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-24 | mouth numbness, mouth tingling |
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ...
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Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-25 | swollen tongue |
Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaint...
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Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation. Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
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| 57 | 2021-01-25 | ear itchiness | Numbness & tingling hands & feet, throat itching, b/l ear itching |
| 57 | 2021-01-25 | mouth tingling |
Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red...
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Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red and blotchy. She states she feels the need to frequently clear throat but is not short of breath. She states her lips feel tingly. No angioedema noted, redness is not spreading from palms of hands. No redness or rashes noted at injection site. Pt was given 50mg of diphenhydramine prior to leaving. She waited in lobby with staff observation for another 15 minutes, Redness in hands was resolved. Educated pt to call emergency services should symptoms persist or worsen. Pt verbalizes understanding. This RN will call later today and tomorrow to follow up with pt.
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| 57 | 2021-01-25 | mouth tingling |
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte...
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Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
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| 57 | 2021-01-28 | eye bleeding |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-29 | mouth tingling | Patient with tongue tingling 10 minutes after vaccine. No other symptoms, vitals and exam normal. |
| 57 | 2021-01-31 | ear discomfort, ringing in ears |
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum...
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Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
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| 57 | 2021-01-31 | mouth tingling, ear pain, loss of taste |
Headache over right forehead started 1/28/21 for 24 then sudden runny nose on right nostril, then lo...
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Headache over right forehead started 1/28/21 for 24 then sudden runny nose on right nostril, then loss of taste in right side of tongue started 24 hours later and the other symptoms improved. Mild pain over right cheek and into ear have remained over the past 72 hours along with the loss of taste and funny feeling on right 1/2 of tongue. No facial muscle weakness noted. No change in hearing or vision.
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| 57 | 2021-01-31 | lip itchiness |
I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection si...
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I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection site. About an hour later, my lips and throat starting itching a little bit,
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| 57 | 2021-01-31 | ear discomfort | Minor shock like feeling, which happens sporadically, behind right ear. |
| 57 | 2021-01-31 | swollen tongue |
had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet ...
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had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet of zyrtac after ~15 to 20 minutes, having swelling tongue after ~10 to 15 minutes, took one dose of benadryl ~1 to 2 hour, all symptoms go away
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| 57 | 2021-02-01 | taste disorder |
Nausea, mild on the day of the vaccine. Five days after the vaccination I felt nausea again, a stran...
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Nausea, mild on the day of the vaccine. Five days after the vaccination I felt nausea again, a strange taste in my mouth, and a headache. resembling the senses with the injection of prolia.
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| 57 | 2021-02-01 | eye twitching | Twitching of L eye since 1/13/21 |
| 57 | 2021-02-02 | ear pain |
Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the f...
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Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep Jan 31 - ear pain, headache, slight aches, trouble falling asleep Feb 1 - feeling better, some ear pain, trouble falling asleep
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| 57 | 2021-02-02 | eye pain, swelling around the eyes |
My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a shar...
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My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a sharp pain shoots through my eye. Thanks.
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| 57 | 2021-02-03 | loss of smell, loss of taste |
I had the 1st vaccine on 1/26/21 and on 2/2/21 I woke up that morning and could not smell or taste a...
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I had the 1st vaccine on 1/26/21 and on 2/2/21 I woke up that morning and could not smell or taste anything. I went and got tested, both rapid and PCR, and both came back negative. I have no other symptoms at all. Within 32 hours, my taste and smell have returned.
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| 57 | 2021-02-03 | swollen tongue |
Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130...
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Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy. Took Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief. 6 hours later, awoke with itchy throat and face and took Benadryl 25mg with relief. Next morning, 2/1/2021: 8 am ate my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief. 11:30 ate pretzels and face started itching `15 minutes later. Everything I ate that day caused me to itch 15 min afterwards just like when I would have food reactions when first diagnosed with Alpha Gal and my IGE histamine levels with 3x normal. I increased my Allegra 180mg to 3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours. 48hours after vaccine I was able to decrease Allegra 180mg to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards. My allergist felt the 2nd vaccine may have caused an inflammatory response and flared up my alpha gal symptoms.
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| 57 | 2021-02-03 | dry throat |
Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 pos...
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Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 post vaccination. Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
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| 57 | 2021-02-03 | loss of taste, loss of smell |
she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 w...
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she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
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| 57 | 2021-02-05 | loss of taste, loss of smell |
Sore throat, body ache, 99 temp highest, lost of taste and smell. Was coughing sneezing and are sti...
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Sore throat, body ache, 99 temp highest, lost of taste and smell. Was coughing sneezing and are still coughing. I tested positive on the 25 January.
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| 57 | 2021-02-06 | swollen tongue, lip swelling, mouth tingling |
C/O Tingling, swelling in tongue & lips states had same reaction with 1st dose. Denies Chest Pain, S...
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C/O Tingling, swelling in tongue & lips states had same reaction with 1st dose. Denies Chest Pain, SOB 2 tablets Benadryl 25mg given. Monitored X 20 min ER precautions given. Understood was D/C
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| 57 | 2021-02-07 | dry throat |
My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palat...
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My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palate. Eventually became sore after the 2nd vaccine Lot # EL1284 on 1/23/21 worsened and throat became red under the bumps. To date bumps and redness remain. Soreness comes on and off, lasts hours improves then returns. Also headaches daily since initial vaccine. I saw PMD am currently on Amoxicillin 875 and it is not helping at all.
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| 57 | 2021-02-07 | mouth numbness | Pt reports chest tightness, tongue numbness, normal EKG. Pt recovered |
| 57 | 2021-02-07 | mouth tingling, pain in jaw |
Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, w...
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Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw, couldn't catch my breath with mask on. I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count. I quickly took my coat off. I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on. Pulse was down to 80 bpm. The skin on my face and neck felt like they were burning. The tip of my tongue felt tingly. All subsided until next day, felt fluish, temp 101.5.
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| 57 | 2021-02-07 | mouth tingling |
complained of lips tingling; observed additional 15 minutes; still had some tingling in lips but no ...
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complained of lips tingling; observed additional 15 minutes; still had some tingling in lips but no other reactions.
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| 57 | 2021-02-07 | mouth tingling | several minutes after vaccine dose patient reported funny sensation in her tongue |
| 57 | 2021-02-08 | mouth tingling, swollen tongue |
Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-hea...
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Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-headed. Reports that the first vaccine caused some "slight flushing". She was laid flat on a cot. VSS. Reported that her tongue was starting to swell. Rapid Response code was called and she was transported to the ED.
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| 57 | 2021-02-09 | tongue disorder, mouth tingling |
1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP...
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1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP 146/90 HR 91 RR 20 Sats 98 1500 BP 133/91 HR 86 RR 18 Sats 98
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| 57 | 2021-02-09 | ringing in ears |
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (pr...
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sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering. Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
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| 57 | 2021-02-10 | pain in jaw |
12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering ...
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12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering if it was in ear. Ran along facial nerve. 12/30 pain increased tremendously, exploded. Weird, yucky lesions on face and mouth. My husband asked if could be shingles; positive. 1/12 Neurology. 2/7/2021 Major pain has subsided. Still recovering from Shingles. *2nd vaccination 1/12/2021 7:30 R arm
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| 57 | 2021-02-10 | loss of taste, loss of smell |
Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no ap...
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Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no appetite. Stayed home and the symptoms got better after 4 days.
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| 57 | 2021-02-10 | smell distorsion, taste impairment |
Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing a...
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Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing and lightheaded. I was given water, observed, and told to call for a ride. Felt better in 15 - 20 min. was tired rest of the day.
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| 57 | 2021-02-10 | mouth tingling | lip tingling, dizziness, heart racing had hives 24-48 hours after 1st dose |
| 57 | 2021-02-10 | mouth numbness, mouth tingling |
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness...
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numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-14 | lacrimation increased |
Within 3 hours of dose #1 administration I had a runny nose, watering eyes, chills and sneezing. By...
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Within 3 hours of dose #1 administration I had a runny nose, watering eyes, chills and sneezing. By evening the chills got worse, low-grade fever and fatigue. Unable to do anything except bundle up and sleep it off. Still fatigue, chills, runny nose the next day but no fever. Better by 2nd day after vaccine.
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| 57 | 2021-02-15 | mouth tingling, eye discomfort, visual impairment, mouth numbness |
With initial vaccine on 20 Dec 2020 I had immediate tingling and numbness of left upper and lower li...
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With initial vaccine on 20 Dec 2020 I had immediate tingling and numbness of left upper and lower lip. I went home and took a 60 mg Allegra and 1 Aleve. It subsided. I woke in the morning and the numbness returned so I took 1/2 60 mg Allegra and it subsided. No additional problems from 1st dose. I received 2nd dose on 12 Feb 2021. I felt fine initially. I woke the following day and had completely lost far vision. I could see up close but could not see far and my eyes felt very swollen. I also had right sided headache. The symptoms resolved later that day on 13 Feb 2021 at 5 pm.
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| 57 | 2021-02-17 | pain in jaw, eye strain, hearing loss, toothache, tongue disorder |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-19 | sensitivity to light, vision blurred | Photo / light sensitivity, blurry vision . |
| 57 | 2021-02-19 | ear pain |
Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, sto...
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Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, stomachache.
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| 57 | 2021-02-20 | ear pain |
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness...
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She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
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| 57 | 2021-02-22 | vision blurred |
Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1...
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Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.
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| 57 | 2021-02-23 | eye swelling, bloodshot eyes |
Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next da...
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Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next day. I never get bloodshot eyes.
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| 57 | 2021-02-23 | burning mouth syndrome, vision blurred |
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;...
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I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-02-25 | visual impairment | Dizziness, vision changes, cleared by EMS |
| 57 | 2021-02-27 | mouth numbness |
Patient reports feeling "sides" of tongue numbness for 2nd dose; tongue felt numb in front of tongu...
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Patient reports feeling "sides" of tongue numbness for 2nd dose; tongue felt numb in front of tongue for 1st dose. C/o dizziness. Checked and monitored by EMT until no further symptoms.
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| 57 | 2021-02-27 | loss of taste, mouth pain, eye pain, loss of smell |
Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 a...
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Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 after vaccine I developed chills, headache, fever and extreme weakness which lasted for 10+ hrs. The weakness improved slightly, but continued. Starting 4 days after vaccine, I started to get stinging eyes, nose and mouth, increased nasal congestion and burning in my sinuses. These symptoms are debilitating and are the same ones I had when I was at my sickest with Covid. Whatever sense of smell or taste I had regained disappeared. These symptoms continues to the present.
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| 57 | 2021-02-28 | taste impairment |
side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report...
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side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced side effect of a metallic taste in her mouth, back of throat, and nose on 27Jan2021. The patient wants more information on this. Outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 57 | 2021-03-03 | mouth tingling | tingling all over, tingling lips. Evaluated by EMS-Cleared |
| 57 | 2021-03-04 | oropharyngeal discomfort |
Flu like symptoms. Body aches, head ache, stuffy, runny nose. Swollen raw throat to the point I coul...
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Flu like symptoms. Body aches, head ache, stuffy, runny nose. Swollen raw throat to the point I could not talk. Vaccinated at 3:18 AM current time is 3:34 PM symptoms are current and ongoing.
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| 57 | 2021-03-04 | eye itchiness |
Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm f...
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Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm felt itchy and she noticed red bumps on the inside of her right wrist. She reported the symptoms to the onsite paramedics. She stated that she was placed on a stretcher and given 60 mg of liquid benadryl by the paramedics. She stated she started feeling dizzy, but after 3 minutes the dizziness resolved. She stated that soon after that the itchy right palm resolved, and the red spots on her right wrist diminished. She stated the paramedics took her blood pressure, 150/100 and placed her on oxygen. She stated she was monitored until 1:30 pm, then was discharged, at the time of discharge she had no dizziness, no itching, and only slight red bumps on her wrist. When she got home she stated her eyes felt itchy at about 5:30 pm, she took 2 OTC benadryl tablets, the symptoms resolved. She has been asymptomatic since that time.
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| 57 | 2021-03-04 | hearing loss |
Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Un...
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Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-03-05 | hearing loss, ringing in ears | Headache, ear ringing, muffled hearing, fingers oh left side of head |
| 57 | 2021-03-06 | tongue disorder |
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt...
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Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
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| 57 | 2021-03-07 | mouth numbness |
Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved...
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Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved with Benadryl 50 mg, similar symptoms 4 hours later which again improved with Benadryl
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| 57 | 2021-03-07 | swollen tongue, eye twitching |
Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tong...
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Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tongue started to feel bigger and to itch at the back, throat also started to feel tight. Monitored by EMTs in parking lot. Given oral Benadyl. Was not transported to hospital. Husband came to pick her up. Stated a few hours later felt pressure in windpipe at level of clavicles & had difficulty breathing. Stated sleep the rest of the day. Denies HA, fever, or chills. Stated throat felt better the next day though still feels pressure at base of throat. Also complaining of occasional "brain zap" (zing in brain that then causes eye to twitch). States that since tongue started feeling big she has had trouble talking--words coming out funny. States that is still happening.
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| 57 | 2021-03-07 | mouth tingling, ear discomfort, mouth numbness | Tongue began tingling and became numb for about an hour. Sneezing, full feeling in ears. |
| 57 | 2021-03-08 | thirst |
Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm an...
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Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm and pain and symptoms lasted about 24 hrs
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| 57 | 2021-03-08 | mouth numbness | My lips and tongue became number 30 minutes after the shot. They stayed numb about 6 hours. |
| 57 | 2021-03-08 | loss of smell, loss of taste |
hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, ...
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hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain, vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and taste, tingly limbs gone but severe pain behind right knee, ruled out blood clot, smell back, taste not all the way returned, pain continuous
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| 57 | 2021-03-09 | dry mouth |
Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/...
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Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/p-158/90. I was lightheaded and thought I was going to pass out. My blood pressure has never been that high. Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.) This lasted about 8 min and then my HR started to go back down.
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| 57 | 2021-03-10 | ringing in ears, deafness |
Within minutes of receiving second dose of the vaccine, I had a severe pain in the right side of my ...
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Within minutes of receiving second dose of the vaccine, I had a severe pain in the right side of my neck. I waited 15 minutes, but felt I could not leave as I was diaphoretic and dizzy when I stood up. I waiting up to 45 minutes until I could manage to leave after receiving bottled water and orange juice. About 5 days later, I experienced tinnitus in my left ear (swooshing sound 24/7 that beat to my pulse.) I went to an ENT appointment several weeks after and was examined. Anatomically there was no findings. The audiology report showed moderate hearing loss in my left ear. High dose steroids were prescribed. I am on day 9 of the Prednisone without any relief of the tinnitus or improvement in my hearing.
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| 57 | 2021-03-11 | swelling around the eyes |
Day 4 after shot - both eyelids were sensitive to touch. Severe pain in both knees. Day 5 both eyel...
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Day 4 after shot - both eyelids were sensitive to touch. Severe pain in both knees. Day 5 both eyelids were puffy and swollen. Severe pain in both knees. Day 7 - both issues had subsided but still discomfort
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| 57 | 2021-03-12 | mouth numbness |
As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I...
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As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I could feel my tongue getting numb. I told the pharmacist & after about 15 minutes I asked if I could take my Benadryl. So it sort of slowed it down but I still had the tingling and numbing . It?s been 3 days and I?m still experiencing the numbing of my tongue .
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| 57 | 2021-03-13 | swollen tongue |
Patient presents today from the vaccine clinic with concerns for tongue swelling. She states she got...
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Patient presents today from the vaccine clinic with concerns for tongue swelling. She states she got her first dose of the Pfizer COVID vaccine today and shortly after developed some swelling in her tongue. She was given a dose of 25 mg of benadryl. She feels much better now that she is at the clinic and wonders if her tongue was just dry.
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| 57 | 2021-03-14 | eye pain |
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (...
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. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
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| 57 | 2021-03-14 | tongue disorder, mouth tingling, mouth numbness |
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin...
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11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
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| 57 | 2021-03-14 | ear pain | 99 fever, chills, headache, double ear ache, fatigue |
| 57 | 2021-03-14 | mouth itchiness |
Approximately 15 minutes after receiving injection, patient complained of itching around her mouth. ...
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Approximately 15 minutes after receiving injection, patient complained of itching around her mouth. She told nurse that she had a shellfish allergy, although no allergies were listed on her consent form. Diphenhydramine 50mg was administered. Patient waited 10 minutes after receiving diphenhydramine before leaving.
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| 57 | 2021-03-14 | ear itchiness, swollen tongue |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-15 | ringing in ears, hearing loss |
Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing pro...
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Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing progressed to right ear; tinnitus is so loud that it wakes me up at night and makes falling asleep difficult
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| 57 | 2021-03-15 | swollen tongue, tongue itchiness | Developed itching and swelling of face and tongue, confirmed SOB. |
| 57 | 2021-03-15 | swollen tongue |
Pt received 1st dose of Pfizer vaccine at Convention Center vaccination site and about 10 minutes a...
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Pt received 1st dose of Pfizer vaccine at Convention Center vaccination site and about 10 minutes after receiving the vaccine she began to complain of dizziness, scratchy throat and mild tongue swelling. Pt reports that she has multiple allergies (especially tree nuts). BP 138/80. EMS on scene. Pt was administered 25 mg IM Benadryl and EMS transported pt to Hospital ED.
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| 57 | 2021-03-16 | mouth tingling |
Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and...
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Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and to side of the nose. It lasted until I went to bed. Symptoms had disappeared by the time I woke up the next day
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| 57 | 2021-03-16 | ringing in ears |
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days af...
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Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
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| 57 | 2021-03-18 | oropharyngeal discomfort |
10:45 patient complained itchy uncomfortable feeling in her throat. Was able to swallow and move air...
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10:45 patient complained itchy uncomfortable feeling in her throat. Was able to swallow and move air. She stated she did not come to clinic with this complaint. Benadryl 25mg given PO with 16 Oz of water. Observation per NP and EMS. vs 10:47 190/106/ SAT on RA 99%. 10:55 BP 200/113, HR 75; SAT 99 RA. Lungs clear, moving air, no SOB, no stridor or wheezing. Moved patient on stretcher to more private area with husband. 11:35 - No further complaints of itchy throat. BP 163/93;HR 75; R 20. Erythema noted on posterior pharynx. Uvula midline. Discharged home 11:35.
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| 57 | 2021-03-18 | ringing in ears, eye itchiness | Itchy face, red inflamed and itchy hands, ringing of the ears |
| 57 | 2021-03-18 | tongue itchiness |
Patient with history of anaphylaxis to previous vaccines and food/medication had immediate sensation...
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Patient with history of anaphylaxis to previous vaccines and food/medication had immediate sensation of tongue itching and reported "tightness in throat" post vaccine. EMS administered 50 mg Benadryl IM, recommended transportation to hospital which patient declined.
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| 57 | 2021-03-18 | ringing in ears |
headache for 3 days left ear rang for 5 days (shot in left arm) both ears ring since (normal tinnitu...
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headache for 3 days left ear rang for 5 days (shot in left arm) both ears ring since (normal tinnitus not loud and different sound than sound after shot)
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| 57 | 2021-03-19 | mouth tingling, oropharyngeal discomfort, taste disorder | tingling in tongue & then having bad taste in mouth; not swelling in lips or tongue; scratchy throat |
| 57 | 2021-03-20 | ringing in ears | Tinnitus Ongoing, high pitched ringing in both ears. Sometimes with 2 tones, one higher, one lower. |
| 57 | 2021-03-21 | oropharyngeal discomfort |
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left...
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57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection. Physical Exam: Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally Skin: no injection site erythema or swelling. No rash. No lip/tongue swelling or narrowing of oropharynx. Plan: Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance. She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
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| 57 | 2021-03-21 | mouth tingling |
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a...
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About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in lips. We moved her to the floor and laid her flat with head raised as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was called. Rescue squad arrived stabilized her and transported to hospital.
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| 57 | 2021-03-21 | swollen tongue |
Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, so...
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Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, soon was unable to walk due to vertigo, then chills and extreme nausea like I would vomit but I did not.
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| 57 | 2021-03-21 | ringing in ears |
Intense ringing in left ear post vaccine Chronic nausea Fatigue muscle weakness low grade headache a...
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Intense ringing in left ear post vaccine Chronic nausea Fatigue muscle weakness low grade headache at times Treatment: Tylenol, Excedrin migraine
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| 57 | 2021-03-21 | oropharyngeal discomfort |
Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient...
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Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient was complaining of chest tightness, throat closing sensation, "weird" feeling over body.
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| 57 | 2021-03-21 | ringing in ears |
Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Le...
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Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Legs ached the day of the shot and the day after but ok now
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| 57 | 2021-03-21 | ringing in ears |
Saturday, within 6-8 hours started with fatigue. Then later that evening chills, headache, fever, a...
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Saturday, within 6-8 hours started with fatigue. Then later that evening chills, headache, fever, and aches. During the first night my ear started kind of ringing and feeling in a funnel or clogged or something (different from anything experienced before). Sunday, continued with fatigue, headache, fever, body aches, generally not feeling well, and ear continued to get worse with some hearing loss. Now today (Monday) I can't hear as well in my left ear and it's a type of ringing and still feeling clogged or in tunnel or something like that. Hard to describe... but I can't hear as well in that ear.
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| 57 | 2021-03-22 | lip swelling, mouth tingling |
My tongue felt tingly when I was sitting for the 1st 15 minutes but I figured that was nerves. Aroun...
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My tongue felt tingly when I was sitting for the 1st 15 minutes but I figured that was nerves. Around 2 hours later I felt the inside of my lips started mildly swelling. It is the same now no better no worse.
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| 57 | 2021-03-22 | mouth discomfort |
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tin...
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Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tingling in arms and lips burning/numb, no difficulty breathing was monitored in store for 1 hour, no epipen needed, advised to take benadryl
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| 57 | 2021-03-23 | tongue disorder, mouth numbness |
Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue ...
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Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue thickness, "feels weird". Macular Rash mid sternum noted by on site physician. No respiratory distress noted. No epinephrine administered.
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| 57 | 2021-03-23 | mouth tingling |
Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vac...
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Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was almost gone. Next few days left lower side of face still felt different. 10:00 pm (29 hours after vaccine) started with chills and body aches. Next morning 6:00am was very tired and felt the same. Took 2 Ibuprofen. Dozed on and off in morning. Felt better in afternoon. Around 6pm started feeling chills and achy. Took 2 more ibuprofen. Arm was sore. Next morning, had to work. Felt tired and brain fog all day. Slight achy. Next day, felt about 90% back to normal.
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| 57 | 2021-03-24 | lip swelling, swollen tongue |
A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area,...
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A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area, I felt an itching sensation on my left forearm which was followed by the same itching feeling on my neck. Then a couple of minutes later my lips felt slightly swollen and my throat was a little scratchy. I told a nurse and she moved me to a chair closest to an oxygen tank. I?m a retired paramedic so I knew I was having a mild allergic reaction. There was never any wheezing. I also had a headache and felt lightheaded. The nurses monitored me 15 minutes longer than the required 15 minutes. I asked them if I should take some Benadryl for the symptoms. They asked if I was driving and said to take it once I got home. The symptoms continued for an hour with added swollen tongue, red lips and blotchy skin spots on my face and feeling tired. Once I took 50mg of Benadryl the symptoms gradually dissipated over 4 hours. I?m concerned about how I will react with my second dose. My MD recommended 25mg of Benadryl before my second Pfizer vaccine and 25mg after if needed.
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| 57 | 2021-03-24 | ear discomfort |
Adverse Events: Throat grab (immediate), Throat swelling, ears popping, difficulty swallowing Treatm...
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Adverse Events: Throat grab (immediate), Throat swelling, ears popping, difficulty swallowing Treatment: Resident "self-medicated" and took 40mg prednisone, 50 mg Benadryl, 1 inhaler of Albudiral Outcomes: Parked at hospital, waited for reaction to subdue. Resident left the vaccine site unauthorized before her 15 minute waiting period.
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| 57 | 2021-03-24 | ringing in ears | tinnitus |
| 57 | 2021-03-25 | ringing in ears | Increase in tinnitus |
| 57 | 2021-03-25 | ringing in ears | Loud ringing in my ears |
| 57 | 2021-03-25 | taste impairment |
Pt. stated she got a headache a minute after she got vaccinated. It was a sharp pain at first and t...
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Pt. stated she got a headache a minute after she got vaccinated. It was a sharp pain at first and then it was dull. Pt. also reported a metallic taste. Vitals signs taken at 11:45 am: BP 148/69, HR 87, O2 Sat 98%, R 18. At 11:57 am pt. stated she is feeling better, headache is almost gone, she wants to go home. Pt. went home at 12:02 pm.
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| 57 | 2021-03-25 | swollen tongue | Tongue redness and swelling |
| 57 | 2021-03-25 | mouth tingling | erythematous hives around neck, tongue tingling. |
| 57 | 2021-03-26 | swollen tongue | Swollen tongue, scratching throat, eruption of psoriasis |
| 57 | 2021-03-27 | eye pain |
Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling u...
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Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling up both sides of head into temples. Painful temples when touched. Headache was constant throughout the day (1-2) and would flare up 3-4 times a day (6-7). Sometimes relived by Tylenol. Often caused eye pain when severe.
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| 57 | 2021-03-28 | loss of taste | Loss of taste. |
| 57 | 2021-03-28 | swollen tongue |
Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked...
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Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked in mirror. Tongue was 3 times typical size! Ears hot and itching. Airway compromised. Tongue continued to enlarge and throat tighter. Hives on face.
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| 57 | 2021-03-29 | deafness |
first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; first dose of BNT162B2:19Dec2...
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first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; hearing loss; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), via unspecified route of administration on 05Jan2021 (at the age of 57 years) at a single dose in the left arm for COVID-19 immunization. Medical history included 'hypothyroid'. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 11:00 AM (age: 57-years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 at 16:00, the patient had hearing loss. The event resulted to physician office visit. The patient received steroids as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
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| 57 | 2021-03-30 | taste impairment |
Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female pati...
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Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 16:30 (Batch/Lot Number: EK9231) as single dose for an Covid-19 immunization.The patient had none medical his-tory There were no concomitant medications.Calling about the Covid-19 Vaccine she states that she got her 1st dose yesterday, 28Jan2021. About 15 minutes after, she got an odd metallic taste in her mouth that she still has. she enquired that this is not a side effect that was listed.Vaccination Facility type is Hospital.The outcome was not recovered.
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| 57 | 2021-03-30 | tongue disorder |
temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mou...
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temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
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| 57 | 2021-04-10 | loss of taste, ringing in ears |
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp...
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Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
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| 57 | 2021-04-11 | mouth numbness, mouth tingling | c/o heavy tongue and numbness in the lips |
| 57 | 2021-04-13 | oropharyngeal discomfort |
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Ex...
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Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Excess saliva. As the pain persisted the pain radiated to the left arm/shoulder. We sought help at our local emergency department where she was found to be in new onset atrial fibrillation. A battery of tests were ordered including a troponin which was noted to be: 1.48. She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
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| 57 | 2021-04-17 | eye discomfort |
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q...
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breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
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| 57 | 2021-04-17 | visual impairment |
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ...
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tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
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| 57 | 2021-04-24 | ear discomfort, deafness, ringing in ears |
deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient)...
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deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0105) via an unspecified route of administration into the right arm on 05Apr2021 15:45 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, hypothyroidism and asthma. Patient was not pregnant. Concomitant medications included simvastatin (SIMVASTATIN), quetiapine (QUETIAPINE), magnesium (MAGNESIUM), acetylsalicylic acid (ASPIRIN (E.C.))and bepotastine besilate (POTAS). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) into the right arm on 16Mar2021 01:00 PM (at the age of 57-years-old) for COVID-19 immunization. On 06Apr2021, patient experienced deafness, tinnitus and ear pressure. The patient did not receive treatment for the events reported. Outcome of events recovered on Apr2021.
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| 57 | 2021-04-24 | thirst |
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p...
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possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
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| 57 | 2021-04-27 | mouth tingling, toothache |
4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis,...
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4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die 1:13pm took 2 Benadryl 25mg 5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21 12:30am took 1 Benadryl 25mg (weird feeling in my tongue) 1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes 1:58pm took 1 Benadryl 25mg " " 2:19pm took 1 Benadryl 25mg " " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
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| 57 | 2021-05-04 | ringing in ears, deafness, extreme sound sensitivity |
moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consum...
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moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 10Mar2021 13:00 at single dose for covid-19 immunisation. The patient's medical history included hypertension. The patient was not pregnant at time of vaccination. The patient's concomitant medications included desvenlafaxine, candesartan, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and azelastine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264) via an unspecified route of administration, administered in Arm Left first dose on 17Feb2021 for covid-19 immunisation. On 11Mar2021 14:00, the patient experienced moderate hearing loss confirmed by doctor hyperacusiss and tinnitus. The patient was treated with oral steroids. The events cause physician office visit. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 57 | 2021-05-06 | oropharyngeal discomfort |
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150...
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anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
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| 57 | 2021-05-10 | mouth tingling, mouth swelling |
Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second C...
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Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second COVID vaccine on Friday. Symptoms consisted of perioral tingling, some possible oral swelling, and then subsequent shortness of breath with labored breathing. Initial treatments in the emergency room did result in some symptomatic benefit, however, the patient continued to have an oxygen requirement and demonstrated persistent symptoms of anaphylaxis. She was then admitted to the intensive care unit for higher level intervention.
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| 58 | 2021-01-01 | mouth tingling | Peri-oral tingling, shortness of breath, nausea immediately after injection |
| 58 | 2021-01-03 | deafness unilateral |
I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous repor...
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I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.
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| 58 | 2021-01-03 | ear discomfort |
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my ...
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S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
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| 58 | 2021-01-03 | mouth tingling, mouth numbness | Tingling, numbness lips and tongue, tightness in throat. Benadryl taken |
| 58 | 2021-01-05 | dry eye, dry mouth |
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s...
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Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-05 | taste impairment | Metallic taste; injection site pain Narrative: |
| 58 | 2021-01-06 | deafness unilateral, ringing in ears |
Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with ...
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Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with some ringing, vertigo and then just silence. I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same. As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20. She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss. There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.
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| 58 | 2021-01-06 | mouth numbness |
tongue felt numb, denied shortness of breath. Benadryl 25mg given po, no rash, patient left after 20...
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tongue felt numb, denied shortness of breath. Benadryl 25mg given po, no rash, patient left after 20 minute observation after Benadryl given.
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| 58 | 2021-01-07 | vision blurred | Bad headache, dizzy, very tired, nausea, blurred vision. |
| 58 | 2021-01-07 | mouth tingling |
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton...
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Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
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| 58 | 2021-01-07 | lip swelling |
Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, So...
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Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, Solumedrol and Pepcid given. Patient taken to Care Center for observation and further care.
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| 58 | 2021-01-07 | swollen tongue | Felt "not right", minor 'thickness of my tongue', tightness of airway (all minor in severity) |
| 58 | 2021-01-07 | ringing in ears, taste impairment |
Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in...
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Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
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| 58 | 2021-01-07 | swollen tongue | Swelling of the tongue, feeling "not right", tightening of the airway (all mild and short duration) |
| 58 | 2021-01-08 | swelling of eyelid, lip swelling |
1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours. 1/2/21 minor eye...
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1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours. 1/2/21 minor eyelid swelling . Took 1dose of Benadryl and condition resolved overnight. 1/4/21 significant lip swelling. Took 3 doses of Benadryl. Condition resolved in 24 hours.
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| 58 | 2021-01-08 | lip swelling |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | vision blurred | Bad headache, dizzy, blurred vision, nausea, very tired. vomiting. |
| 58 | 2021-01-08 | mouth tingling, taste impairment |
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya...
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Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
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| 58 | 2021-01-08 | eye pain |
On the day of taking the vaccines had joint pains all over mainly involving the arms but they subsid...
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On the day of taking the vaccines had joint pains all over mainly involving the arms but they subsided. On the next day noticed redness and pain in the left eye. On 1/6/21 noticed diminished vision and blurriness in the left eye. Called opthalmology ED and was seen the next day on 1/7/2021 morning . Was diagnosed with left uveitis. I was seen by the on call doctor. There are many doctors involved in my care. My previous episodes of uveitis have been mostly in the right eye and the vision was not affected, The doctors involved in my care are not sure if this was just a coincidence, was an exacerbation of the preexisting pathology or was something new. I have asked to put the eye drops every hourly but the vision has not completely improved. I don't use the eye drops in the night and when I get up in the morning it is still very hard to read. It is an unusual episode of uveitis as typically my left eye is not involved and I have never had this much diminished vision , I am supposed to put the drops every one hourly until 1/11/2021. I have informed my PCP, Rheumatologist, regular eye doctor. I will inform my ID doctor Dr .
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| 58 | 2021-01-10 | lacrimation increased |
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an...
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Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
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| 58 | 2021-01-10 | mouth swelling, swollen tongue |
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to...
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Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
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| 58 | 2021-01-11 | eye discomfort |
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad...
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Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
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| 58 | 2021-01-11 | ringing in ears |
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We...
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Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
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| 58 | 2021-01-11 | ringing in ears, hearing loss |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-11 | mouth numbness |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-11 | loss of taste, loss of smell |
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste a...
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tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
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| 58 | 2021-01-13 | ringing in ears | Arm soreness, headache , body aches, dizzy, ears ringing |
| 58 | 2021-01-13 | mouth tingling, taste impairment |
Pt voiced metallic taste in mouth and lips tingling. Voiced initial compliant @ 1350. Left observa...
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Pt voiced metallic taste in mouth and lips tingling. Voiced initial compliant @ 1350. Left observation @ 1415, denies any s/s of distress not trouble w/ SOB or breathing.
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| 58 | 2021-01-17 | swollen tongue, lip swelling, mouth tingling |
Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Pat...
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Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Patient also reports that she experienced tongue swelling, lip swelling, difficulty swallowing and rash on her back that developed 1 hour after vaccine. Patient did not seek immediate medical treatment and will receive treatment at Occupational Health.
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| 58 | 2021-01-17 | eye swelling |
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on...
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Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
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| 58 | 2021-01-17 | mouth tingling |
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte...
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Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
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| 58 | 2021-01-17 | deafness |
Within 1 hour MILD light headiness, passing headache, chills, sweating, Within 3 hours LEFT EAR HEA...
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Within 1 hour MILD light headiness, passing headache, chills, sweating, Within 3 hours LEFT EAR HEARING LOSS about 25% to 50% have not yet resolved & ENT office recommends PCP prescribe prednisone rapid taper pack ASAP
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| 58 | 2021-01-18 | mouth tingling, dry mouth |
Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a ra...
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Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a rash to left upper arm. 0954: O2 sats 99%, HR 130 bpm, BP 150/90. Offered PO Benadryl per vaccine standing orders for adverse reactions. Patient refused PO Benadryl. O2 at 2L/NC applied at this time. EMS notified and in route. 1000: Patient remains very anxious and complains of dry mouth, dizzyness and tingling tongue. Attempted to administer EpiPen per vaccine standing orders for adverse reaction. Patient refused EpiPen. 1002: EMS on site. Patient continues to refuse EpiPen. O2 sats 99% on 2L/NC, HR 123 bpm, and BP 137/76. Patient ambulated with EMS personnel outside. After ambulating with EMS personnel, patient stated she felt better and refused to be transported to the hospital. Returned inside for follow up and monitoring. Late Entry 1025: Patient waiting to sign AMA form and had another episode in the hallway. Patient stated she did not feel right and squatted in the hallway. Staff assisted her to a chair. EMS notified and in route. Dr. notified. 1028: O2 sats 99%, HR 94 bpm and BP 138/102. Patient refused EpiPen at this time. Patient complains of feeling dizzy and short of breath. O2 at 2L/NC applied for comfort. 1032: O2 sats 98% on 2L/NC, HR 88 bpm, and BP 128/84. 1035: Dr. at bedside assessing patient. 1040: EMS here. Patient agreed to be transported to the local hospital for evaluation. O2 sats 98% on 2L/NC, HR 86 bpm, and BP 140/81.
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| 58 | 2021-01-18 | vision blurred |
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,...
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Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
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| 58 | 2021-01-19 | eye movement disorder |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | mouth numbness |
I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pin...
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I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pinna. The tip of my tongue also became numb. Symptoms lasted for 45 minutes.
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| 58 | 2021-01-20 | tongue discomfort, taste impairment, mouth tingling, mouth numbness |
Around 2pm the day of the vaccine, my tongue started to feel like it was burned, rough , and someon...
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Around 2pm the day of the vaccine, my tongue started to feel like it was burned, rough , and someone spilled novacaine on the surface of it. My throat also started to hurt, which lasted until about 6pm. The day after the vaccine, (today) my tongue still feels the same, and i have a metallic taste in my mouth when I eat.
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| 58 | 2021-01-20 | mouth tingling, lip swelling | Complained of tingling and swelling in the lips about 10 minutes after receiving vaccine |
| 58 | 2021-01-20 | taste disorder |
I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throa...
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I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throat get bad; I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe; I started hyperventilating because I was scared; I started hyperventilating because I was scared; I felt strange but not sick or anything like that, it hit me like with a ton of bricks; I was shaking so bad I couldn't even hold anything; I was aching all the way from head to toe; I got my first Pfizer BioNTech COVID 19 Vaccine on 22Dec/And then I had my second one on 08Jan; I have residual like I am sill aching in my back; I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally; I had sort of a cough but not like I urge to cough but it was not like chronic; Muscle soreness; still tired; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on right deltoid on 08Jan2021 08:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left deltoid on 22Dec2020 at single dose for covid-19 immunisation. The patient stated she got her first Pfizer BioNTech COVID 19 Vaccine on 22Dec2020 and had no issues really with that one. And then she had second one on 08Jan2021. The first she got in her left deltoid and the second one she had on 08Jan2021, she had in her right deltoid. It's towards 8:30 in the morning roughly is when she had it. So, during the day went on 08Jan2021, she felt strange but not sick or anything like that. And the day went on to eat something and then came home. And then she'd say at around 7:30 it hit her like with a ton of bricks. She was shaking so bad, she couldn't even hold anything. And then she was aching all the way from head to toe. And she was like she will get her tooth brush at least. So, she brushed her teeth and then all of a sudden her throat closed up on 08Jan2021 around 7:30 pm and she couldn't breathe. And she stated she was like "oh my gosh and then it sort of opened up enough for me to scream for my husband, I yell for him to come and then it did it again, it closed up again. And when he came, I started hyperventilating because I was scared. And he calmed me down and rub my back and everything, and it went away. But it scared me. But the shaking lasted probably all through night maybe till 3 in the morning because I tried not to take anything and I probably took 2 Advil. And now I have residual like I am sill aching in my back. And it's weird, in morning I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally. And then I had sort of a cough but not like I urge to cough but it was not like chronic. Not a lot but it's there like if you urge to cough, it doesn't happen a lot. " The patient stated "It started on 08Jan2021 around 7:30 pm, when my throat get bad. I have muscle soreness specially in my back and I don't know in the taste in the morning the food doesn't taste right but then like it's fine towards the afternoon. And I am still tired and a slight like cough. But the cough isn't really anything, if I get urge to cough. It's not all day, it's not chronic at all." The patient started to took Advil as a treatment and stated "Well I started to because it was like 3:30 in the morning, or 2 or 3 in the morning I did take 2 Advil. And they helped with that pain." The outcome of the event taste abnormality was recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-01-20 | swollen tongue | Nausea, headache, chills, sweats, swelling to the tongue, SOB, loss of appetite, shakiness, |
| 58 | 2021-01-20 | mouth numbness, thirst |
Right after she received the vaccination she felt dizzy and very thirsty. Her tongue was also numb f...
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Right after she received the vaccination she felt dizzy and very thirsty. Her tongue was also numb for 3 days.
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| 58 | 2021-01-20 | mouth numbness |
Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb ...
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Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb for 3 days.
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| 58 | 2021-01-21 | vision blurred |
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v...
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Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
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| 58 | 2021-01-21 | eye swelling |
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ...
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On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
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| 58 | 2021-01-21 | lip swelling, vision blurred, ringing in ears, swollen tongue, mouth numbness |
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s...
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Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
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| 58 | 2021-01-21 | mouth itchiness |
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu...
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Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
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| 58 | 2021-01-22 | ringing in ears |
Continuous tinnitus started the day after my second vaccine administration. No treatment taken. Has ...
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Continuous tinnitus started the day after my second vaccine administration. No treatment taken. Has not gone away.
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| 58 | 2021-01-24 | lip swelling |
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev...
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Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
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| 58 | 2021-01-25 | taste impairment |
Foul taste. Everything tastes like it was slathered in old butter. Nothing tastes right; This is a s...
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Foul taste. Everything tastes like it was slathered in old butter. Nothing tastes right; This is a spontaneous report from a contactable nurse reporting for herself. A 58-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), via an unspecified route of administration, on 06Jan2021 04:30 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient was not pregnant at the time of vaccination. Medical history included asthma and hypothyroidism. The patient had no known allergies. Concomitant medications included unspecified medications. It was reported that the patient received other medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: not reported), via an unspecified route of administration, on 16Dec2020 11:00 AM at a single dose on the right arm for COVID-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 04:30 AM, the patient experienced "Foul taste, everything tastes like it was slathered in old butter, nothing tastes right." The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any treatment for the reported adverse event. Outcome of the event was not recovered.
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| 58 | 2021-01-25 | mouth tingling |
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI...
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PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
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| 58 | 2021-01-25 | mouth tingling, mouth numbness |
muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around...
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muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around the mouth; This is a spontaneous report from a contactable other HCP(Patient). A 58-year-old female patient received second dose BNT162B2(lot number EK9231), via an unspecified route of administration at Arm Left on 12Jan2021 11:45 at 58 years old at single dose for COVID-19 immunization. The patient medical history was Graves' disease and COVID-19. Concomitant medication included ibuprofen(MOTRIN) and diclofenac sodium. The patient previously took Percocet and Darvocet, both experienced Drug Allergy. The Historical Vaccine was first dose BNT162B2(lot number EJ1685) received on 22Dec202011:45 at 58 years old at Left arm and experienced body ache, muscle aches, feeling like coming down with the flu. While receiving the product the patient felt numbness and tingling around the mouth that went away in about 30 minutes on 12Jan2021 then the next day 13Jan2021 02:30 muscle aches and rather significant stomach pain. There was no treatment received for all the events. There was no covid tested post vaccination. There was no other vaccine in four weeks. The outcome of events numbness and tingling around the mouth was recovered on 12Jan2021 , the events muscle aches and stomach pain was recovering.
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| 58 | 2021-01-25 | feeling of choking |
tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway c...
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tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway compromise. Sensation changed to a numbness but did not worsen. Patient given Benadryl and Pepcid, monitored. Improvement in symptoms noted, discharged home.
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| 58 | 2021-01-26 | ringing in ears |
15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud...
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15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud. She also reports her parkinson symptoms are increasing. Shaking of arms and legs were observed. Patient also reported nausea.
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| 58 | 2021-01-26 | ear pain |
Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening aro...
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Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening around 6-7PM. The next evening I was actually talking to my sister and I coughed and she brought to my attention about my cough. It was late around 7PM. The next morning, around 4AM I woke up with a terrible ear ache. I called my doctor on the 28th and he suggested a COVID test at his office. On Thursday 12/31/20 in the morning he called me giving me positive results for COVID.
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| 58 | 2021-01-27 | mouth tingling, mouth numbness |
"I just wanted to follow up with information about what I experienced from the second COVID 19 vacci...
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"I just wanted to follow up with information about what I experienced from the second COVID 19 vaccine from Pfizer. I stayed 30 minutes after the second vaccine was given and felt fine. However within another 10-15 minutes (so 45 minutes later) I experienced both my lips and tongue tingling and feeling numb. I reported it through the CDC given to us: It lasted approximately 45 minutes with no other symptoms that day."
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| 58 | 2021-01-27 | mouth tingling, taste impairment |
After getting vaccine, pt. had tingling in her lips and a metallic taste in her mouth. This resolve...
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After getting vaccine, pt. had tingling in her lips and a metallic taste in her mouth. This resolved after Benadryl.
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| 58 | 2021-01-27 | deafness, ringing in ears, ear discomfort |
Sudden onset right sensorineural hearing loss day 5 after vaccine. Bilateral worsened tinnitus and a...
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Sudden onset right sensorineural hearing loss day 5 after vaccine. Bilateral worsened tinnitus and aural fullness starting 2 days after vaccine, mildly for a few days after 1st dose of vaccine, then more intensely after second dose. Transtempanic steroid injection seems to be helping hearing loss but increase bilateral tinnitus continues to be more intense than baseline.
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| 58 | 2021-01-27 | mouth pain, pain in jaw |
The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphore...
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The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphoretic, pain to entire right side; right side teeth and jaw pain; general malaise. I took 2 -650mg Tylenol before bed. Pain in the right arm from neck to elbow lasted for 1 week, used 2-650mg Tylenol to tx
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| 58 | 2021-01-28 | loss of smell, loss of taste |
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ...
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After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
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| 58 | 2021-01-28 | dry mouth, thirst |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-28 | ear pain | pt is having ear pain bilaterally, back pain, sob, fatigue |
| 58 | 2021-01-30 | pain in jaw |
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia...
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Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
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| 58 | 2021-01-31 | visual impairment |
Increased fluid in left eye with significant decreased vision started 1 week post immunization; and ...
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Increased fluid in left eye with significant decreased vision started 1 week post immunization; and shingles started 1/29/2021
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| 58 | 2021-01-31 | swollen tongue, taste impairment, lip swelling | Metalic taste in throat Burning in chest lips swelling tongue swelling with swallow difficulty |
| 58 | 2021-01-31 | mouth tingling |
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio...
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Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
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| 58 | 2021-01-31 | ear pain |
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia...
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She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
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| 58 | 2021-02-01 | thirst |
felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and...
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felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.
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| 58 | 2021-02-03 | oropharyngeal discomfort |
@0825am received Dose #2 of Pfizer, resting/lying on the gurney. (due to the experience/adverse rea...
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@0825am received Dose #2 of Pfizer, resting/lying on the gurney. (due to the experience/adverse reaction from Dose #1), water offered. @0835am pt C/o HA, ice pack offered w/ mild relief. still lying on the gurney. @0845am noted pt's voice changed, + coarse/weak, + episode of dry coughing, + "weird feeling inside throat but breathing fine", + HA, + severe fatigue, but denies Dizzniess/N/V/epigastric pain. VS: 36.8(o), 85, 151/95, 20. 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to resting/lying on gurney @0900am pt 's voice slowing returning, coughing less, + HA, continue to deny N/V,dizziness,epigastric pain. pt states "feeling a bit better but very tiring". VS: 36.8(o), 79,140/93, 20, 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to rest on gurney. @0915am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 77, 139/93,18,98%RA @0930am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 76, 138/91,20,97%RA @0945am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 79, 130/90,20,98%RA @10am pt woke up and claimed feeling a lot better, no more HA, no more weird feeling inside throat. + tiredness, but much better. VS: 78, 138/92, 20, 98%RA RN recommends pt to rest at home. strict return precaution explained and discussed.
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| 58 | 2021-02-03 | eye itchiness | severe itching, especially eyes, ears and throat |
| 58 | 2021-02-07 | lacrimation increased |
Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat ...
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Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Eyes watering; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 20Jan2021 at 08:40 at 0.3 mL, single on arm left for covid-19 immunisation. Medical history included high blood pressure diagnosed for a while. Historical vaccine included flu shot for immunization and experienced allergies. Concomitant medication included hydrochlorothiazide/lisinopril and ascorbic acid/ betacarotene/ biotin/ calcium/ chromium/ colecalciferol/ copper/ folic acid/ iodine/ iron/ lycopene/ magnesium/ manganese/ nicotinamide/ pantothenic acid/ phosphorus/ phytomenadione/ potassium/ pyridoxine hydrochloride/ retinol/ riboflavin/ selenium/ vitamin b1 nos/ vitamin b12 nos/ vitamin e nos/ xantofyl/ zinc (CENTRUM SILVER). Patient had the first Pfizer vaccine on Wednesday, 20Jan2021 at about 8:40AM, yesterday (22Jan2021) she started with allergies and nasal drip in back of throat, eyes watering and sneezing around 10 AM. Stated that this was normal for her to have these allergies this time of the year. Caller reports Temperature of 99.8, "not feverish", no nausea. Caller wanted to know if she was contagious because of the vaccine, if it was possible the vaccine triggered her allergies. States she was just wanting to know if she was able to go to work tomorrow. Caller said "the first time i got the flu shot, it triggered my allergies real bad". Patient was treated symptoms with diphenhydramine hydrochloride (BENADRYL) and stated it got better with the diphenhydramine hydrochloride. Outcome of the events was resolving.
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| 58 | 2021-02-07 | ringing in ears |
The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I...
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The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I had the 1st time was a ringing/buzzing in my ears/head. I again have the same thing this time.; This is a spontaneous report from a contactable healthcare professional who is also the patient. A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL3249), intramuscularly, on 11Jan2021 at 06:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history includes status as pre-diabetic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL1284) on 21Dec2020 at 04:45 in the left arm. The patient is allergic to epinephrine, norethindrone and Comtrex. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as "none." Prior to the vaccination the patient had not received any other vaccination within the last four weeks. On an unspecified date after the second vaccination, the patient experienced ringing/buzzing in her ears/head. She explained that after the first shot she had ringing/buzzing in her ears/head (AER 2020508246) and she again has the same thing this time. She commented that it never really went away before having this second shot. She also said that she only really hears the buzzing when things are quiet. As treatment for the event ringing and buzzing in the head, the patient's primary care physician told her to take "Ginkgo" which she says helps somewhat. The clinical outcomes of the ringing/buzzing in the ear was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-02-08 | lip itchiness, mouth tingling |
58 yo female 2nd dose Pfizer. Pre-medicated with antihistamine 30 minutes prior to inoculation. Appr...
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58 yo female 2nd dose Pfizer. Pre-medicated with antihistamine 30 minutes prior to inoculation. Approximately 15 minutes post-inoculation she complained of tingling on the roof of her mouth and a mild itching sensation on lips. Observed for 30 minutes without intervention. Discharged to home.
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| 58 | 2021-02-09 | taste impairment, hearing loss |
Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost abi...
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Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost ability to walk without a walker, severe weakness, fatigue, dizzy, distortion in hearing, metellic taste, body aches and joint pain, intermittent headache and nausea. No fever no cough.
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| 58 | 2021-02-10 | vision blurred, double vision |
Double Vision. Unable to focus far away . Blurry up close. Urgent care. Primary Dr. 2 eye drs prim...
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Double Vision. Unable to focus far away . Blurry up close. Urgent care. Primary Dr. 2 eye drs primary care three times . Out of work vision issue is on going
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| 58 | 2021-02-10 | ringing in ears, deafness unilateral |
Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a sponta...
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Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-02-11 | swollen tongue | facial/ tongue swelling, hives, shortness of breath, trouble swallowing |
| 58 | 2021-02-15 | taste impairment, mouth tingling |
Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue...
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Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue. About 5 minutes after that, I had a metallic taste in my mouth. I was monitored and my blood pressure was elevated. My pulse was normal. They monitored me for 1 hour and then let me go home. The tingling continued through the night. Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue. Two days after the vaccine, my heart began to race. My blood pressure remained high for approx. 2 1/2 weeks. My heart beat continues to race at times. I followed up with my PCP and cardiologist who both took EKGs which were normal.
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| 58 | 2021-02-16 | mouth tingling | Lip tingling |
| 58 | 2021-02-18 | ringing in ears, deafness | Hearing loss, Tinnitus, Headache |
| 58 | 2021-02-21 | mouth tingling |
Reported tingling tongue. Took own benadryl, monitored for 15 mins, noted resolution of symptoms and...
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Reported tingling tongue. Took own benadryl, monitored for 15 mins, noted resolution of symptoms and d/c home,
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| 58 | 2021-02-22 | ear itchiness, tongue itchiness |
began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 ...
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began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 minutes after administered. Pt took 25mg of personal benadryl. Pt continually monitored for 30 minutes following benadryl administration. Cough resolved after 10 minutes, other symptoms remain unchanged. 25 minutes following benadryl, patient stated symptoms resolved. Pt monitored another 5 minutes, vital signs rechecked. Pt sent home with spouse in stable condition.
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| 58 | 2021-02-23 | oropharyngeal discomfort |
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi...
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Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
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| 58 | 2021-02-23 | lip swelling |
lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 5...
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lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number #EL9267on 14Feb2021 09:00 AM (at 58 year old) at single dose via unspecified route at the left arm, for COVID-19 immunization. Medical history included Anaphylactic reaction to the Capsaicin Family, thyroid and High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID), lisinopril, verapamil and loratadine (CLARITIN). The patient was not pregnant. No COVID prior vaccination. The patient had not been tested for COVID since the vaccination. On 14Feb2021 09:15 AM the patient experienced lips swelling. The outcome of the event was unknown. The patient visited Emergency room for the event and treatment was received, steroid shot and prednisone for 5 days.
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| 58 | 2021-02-24 | ear itchiness |
1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was ...
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1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was brought back to assessment area. Vitals checked 1450- 142/82 1506- 133/90 Recommend diphenhydramine for symptoms- Pt refused treatment recommendation. Emergency Response Team called to discuss with Pt. Pt signed recommendation refusal form and left clinic.
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| 58 | 2021-02-24 | vision blurred |
1st vaccination -Head ache, muscle ache, fever, fatigued- lasting 2 days Ibuprofen and Tylenol be...
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1st vaccination -Head ache, muscle ache, fever, fatigued- lasting 2 days Ibuprofen and Tylenol bedrest 2nd vaccination- Head ache, muscle ache, joint pain, blurry vision, fever fatigued - lasting 3 days Ibuprofen and Tylenol and bedrest
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| 58 | 2021-02-25 | mouth tingling, tongue discomfort |
Progress Notes (Nurse Practitioner) - - Family Medicine Attempt to call patient for follow up vi...
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Progress Notes (Nurse Practitioner) - - Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes APRN (Nurse Practitioner) - - Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Patient: Date: 2/24/2021 MRN: 1356120 Subjective Patient is a 58 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tip of tongue tingling/burning. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to drooling, rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. Pt reports that she may have burned the tip of her tongue this am after eating hot oatmeal. She wanted to be evaluated to be sure if that was the issue and not an allergic reaction. PMH includes HTN: takes 10 mg of Lisinopril ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, cysts, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0912 02/24/21 0920 02/24/21 0927 BP: (!) 144/79 126/82 132/71 Pulse: 75 67 SpO2: 99% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: No visible burn noted to tip of tongue. No swelling or discoloration noted. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Encouraged to monitor symptoms at home. She is aware of f/up care with ED if she does progress in symptoms of allergic reaction. This time I think she has the burnt tip of her tongue sensation. F/up with pcp otherwise. APRN Electronically Signed 2/24/2021 9:40 AM
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| 58 | 2021-02-28 | mouth tingling |
This was second injection. She did have worse reaction to first shot and was sent to ED and also cle...
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This was second injection. She did have worse reaction to first shot and was sent to ED and also cleared by her PCP. This time she has tingling of the tongue. She immediately took Benadryl. Issues subsided and sent home with instructions to call PCP or go to ED if symptoms returned.
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| 58 | 2021-03-01 | loss of smell |
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel...
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Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
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| 58 | 2021-03-02 | swollen tongue, burning mouth syndrome, mouth tingling |
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac...
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Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
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| 58 | 2021-03-02 | lip swelling |
lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of...
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lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of both hands. unable to grasp with both hands, dark spot in middle of hand.
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| 58 | 2021-03-03 | lip swelling |
Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom...
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Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.
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| 58 | 2021-03-04 | loss of taste, loss of smell, taste impairment | Taking Aleve and drinking lots of Water |
| 58 | 2021-03-05 | vision blurred |
Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, ...
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Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, difficulty focusing eyes. Aches started at 6:30 am. High heart rate noted at 10:00 am. The rest came on in the afternoon. Took my vitals when I got home from work (7 pm). Chills, cold extremities through the night. By 5am, temp down to 100. By noon next day, BP and HR normal. Dizziness still comes and goes.
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| 58 | 2021-03-06 | dry mouth, thirst | Extreme dry mouth, sinuses and lips. Very thirsty. |
| 58 | 2021-03-06 | bloodshot eyes, eye pain |
Yes got very painful at night and upon wakening. In the morning they were very puzzled and red. Pu...
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Yes got very painful at night and upon wakening. In the morning they were very puzzled and red. Put Systane eye drops in a couple of time during the day and also put ice pack on eyes which helped. Definitely something going on with my eyes. I never use eye drops or have to put ice on my eyes. Hopefully will be better soon but wanted it noted.
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| 58 | 2021-03-07 | taste disorder |
Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever ...
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Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever (100), chills, all over body aches, sore throat, alteration of taste, heaviness in chest, nausea. The headache lasted a few days .... each morning for the next 4 days I awaoke with headaches
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| 58 | 2021-03-07 | sensitivity to light, extreme sound sensitivity |
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila...
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felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-03-07 | lip swelling, eye irritation |
swollen and irritated lips and eyes, started 24 hours after vaccine 3/5, took over the counter Benad...
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swollen and irritated lips and eyes, started 24 hours after vaccine 3/5, took over the counter Benadryl and called my primary care's office on Monday 3/8
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| 58 | 2021-03-08 | eye pain, eye floaters, eye itchiness |
I developed severe headache for two to three days after getting the 2nd dose of the Covid-19 vaccin...
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I developed severe headache for two to three days after getting the 2nd dose of the Covid-19 vaccine starting approx. 3 hours after the vaccine. I took Celebrex as the head aches were quite severe(7-8/10) with difficulties in focusing due to the pain. I received my first Covid-19 vaccination shot on 12/16/2020 and did not have any significant side effects besides mild pain in my left arm at the injection site the next day and it resolved with no intervention. Then on 01/14/2021 I developed floaters in my right eye that was very sudden around early afternoon that progressed to large black spots obscuring my vision. It was associated with headache and deep eye itching and pain. I was unable to look at the computer and that is when I called my eye doctor and was told to come to see her right away. She then diagnosed me with Posterior Vitreous Detachment and referred me right away to see Dr. retinal specialist.
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| 58 | 2021-03-08 | swelling around the eyes |
My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my ba...
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My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my back, the back of my neck & under my right arm pit. My throat felt itchy. I took benadryl & the swelling around my eyes went down considerably within a few hours. The itchiness persisted until my 2nd dose of benadryl. When I woke up this morning, I was fine.
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| 58 | 2021-03-08 | swollen tongue |
Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the...
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Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the Clinic. At approx. 8:14 ambulance was called to truck stop. Patient was having weakness, shortness of breath and tongue swelling. Patient brought to Emergency Room. See enclosed notes.
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| 58 | 2021-03-08 | taste impairment |
client waiting in post-vaccination area and started to have difficulty breathing. Post-vaccination n...
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client waiting in post-vaccination area and started to have difficulty breathing. Post-vaccination nurse notified Vaccination Team Lead. After 1 minute, difficulty breathing did not decrease, client also reported a metallic taste in mouth. Reaction at 9:32, EAMS called 9:33, Epinephrine administered at 9:34 in right arm, IM. 0.5mL administered per protocol. EMS arrived 9:37. Client placed on stretcher and transfer of care to EMS at 9:43.
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| 58 | 2021-03-08 | double vision, vision blurred |
double vision; blurred/double vision; This is a spontaneous report from a contactable nurse. A 58-ye...
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double vision; blurred/double vision; This is a spontaneous report from a contactable nurse. A 58-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on the left arm on 22Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included elevated B/P. Patient was not pregnant at the time of vaccination. Unspecified medications were received within 2 weeks of vaccination. The patient experienced blurred/double vision on 25Jan2021. Patient had urgent/ emergency care visit for which she was given antibiotics and steroids. She had 2 eye doctors and been to primary doctors twice. Outcome of the events was not recovered. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination on 27Jan2021 (nasal swab: negative).
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| 58 | 2021-03-09 | dry eye, dry mouth, mouth numbness | Numbness in center of face numbness tongue dry eyes dry mouth restless leg |
| 58 | 2021-03-10 | taste impairment, mouth numbness |
15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste i...
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15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste in mouth on right side along with numbness on right side of face, right jawline, ear area, and small portion of tongue. No pain. No swelling. The metal taste dissipated in approximately 1/2 hour but numbness lasted until evening. By next morning, all symptoms were gone.
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| 58 | 2021-03-10 | mouth numbness | Tremors, Itching, Tongue feeling numb, |
| 58 | 2021-03-13 | sensitivity to light, eye irritation |
Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, naus...
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Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light. By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking. Symptoms lasted 3 days. On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
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| 58 | 2021-03-14 | lip swelling |
I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vacc...
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I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021. I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only). Went to bed approx. 10:30 PM and experienced mild chills. I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives. I took a Zyrtec. The itching of hives subsided in approx. 30 minutes. The facial swelling and lower lip swelling subsided in approx. 12-hours. I took and have photos of my face and lips.
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| 58 | 2021-03-15 | vision blurred |
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chip...
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-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24 hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm 48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week) Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
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| 58 | 2021-03-16 | mouth numbness | Numbness in face, neck and mouth. Red Rash on face and neck. Dizzy. |
| 58 | 2021-03-16 | mouth numbness, mouth tingling |
Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated wi...
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Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated with tingling down arms and legs. Blood pressures in the 150/90s, HR 86, 98% O2 saturation, and alert/oriented. Patient was placed in a supine position and monitored. EMS was called as symptoms persisted and increased.
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| 58 | 2021-03-16 | eye pain |
Severe eye pain - began day after vaccine (went to emergency at Hospital three days after vaccine be...
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Severe eye pain - began day after vaccine (went to emergency at Hospital three days after vaccine because pain continued - diagnosed with cornea abrasion but said pain was in a different area - I?m unaware of how it could have occurred); severe pain in both shoulders with difficulty lifting both without pain- I have degenerative disc disease in my cervical spine so I assumed it was associated. However, the pain I?m experiencing is unusual and it?s never occurred like this. This pain also began the day after the vaccine. I used the V-Safe system, but didn?t report either problem because I assumed they weren?t related to the vaccine. But the timing, severity, and unusual nature have me very concerned about a connection to the vaccine.
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| 58 | 2021-03-16 | mouth numbness | facial and tongue numbness for 1 full day and still feeling it at this time |
| 58 | 2021-03-17 | burning mouth syndrome |
A few hours after injection my tongue started to feel sore, almost as if I had scorched it. The fol...
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A few hours after injection my tongue started to feel sore, almost as if I had scorched it. The following day it continued to be sore but only on the side the injection was given (right), it also developed a purplish blister in the area where it is sore. I had my injection on 03/16/2021 today is 03/18/2021 and the blister and soreness is still there. I can still eat and drink normally, it is just uncomfortable to do so.
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| 58 | 2021-03-17 | mouth numbness |
Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of he...
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Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of her tongue and cheek. This lasted about one hour, but the numbness progressed to her left jaw and left cheek and then her whole head. The next morning the numbness was at the base of her skull and lasted most of the day. All symptoms resolved within 48 hours of the vaccine. On 3/16/2021 patient reported slight numbness of her whole head during the day. This resolved within a few hours.
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| 58 | 2021-03-17 | swelling around the eyes, eye swelling |
Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to br...
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Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to breathe. Medic came to my car to assist. Told me to keep window down and take deep slow breathes. This worked, but maybe to minutes later it happened again. My blood pressure and oxygen level was taken. I was given a banana to eat. I ended up calling my husband to pick me up. On the evening of Sunday 3/14, I noticed a red patch on my chest. Monday, 3/15 when I woke up, red patches were on my arms, hands , neck and face. Tuesday, 3/16 the red patches had spread up my arm and my eyes were puffy. I went back to the vaccination site and reported it to a medic. I was told to take Benadryl. Wednesday, 3/17 my right eye was swollen more and puffiness under my eye. My left eye was swollen but not as much. I went to clinic and was given Benadryl and prednisone, and told to go to the emergency room if it gets worse. Today 3/18 blotches still on arms, hands, neck and chest. Swelling on right eye lid has gone down some.
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| 58 | 2021-03-18 | mouth numbness, mouth tingling |
C/o tongue heeling heavy and big. No resp. distress noted. Resp. even and reg. (20). C/o numbness...
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C/o tongue heeling heavy and big. No resp. distress noted. Resp. even and reg. (20). C/o numbness in tongue. BP 134/77, Hr 66, O2 sat 100%\ 10:10 am client stated tongue continues to feel somewhat swollen but better, sensation remains. Tongue observed and did not appear swollen by Paramedics.
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| 58 | 2021-03-18 | mouth tingling, mouth numbness |
Numbness and tingling in lips and tongue, no visible swelling, lasting for about two hours. After nu...
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Numbness and tingling in lips and tongue, no visible swelling, lasting for about two hours. After numbness and tingling had nearly subsided, I took two Benadryl tablets just in case and went to sleep. Upon waking there was no more numbness or tingling. 9. Continued: multivitamin, vitamin D3, melatonin when needed for sleep, Tylenol, probiotics
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| 58 | 2021-03-18 | mouth numbness |
Patient returned to vaccine clinic approximately 2 hrs after receiving Pfizer vaccine. She waited i...
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Patient returned to vaccine clinic approximately 2 hrs after receiving Pfizer vaccine. She waited in vaccine clinic waiting area 15 minutes, then sat in hospital waiting area an additional hour (her own decision) then started feeling numb around her lips and part of her tongue, as well as heartburn symptoms. By the time she reported back to vaccine clinic, she said she was mostly better, but still had some circumoral numbness and the tip of her tongue was numb. Patient evaluated by RN and MD working in vaccine clinic; no swelling noted. Lips and tongue normal in appearance. Pt. denied any shortness of breath. VSS (139/63, HR 100, 95% O2sat). Pt declined to go to ED and discharged home without any other known complications. Patient received second Pfizer vaccine on 3/2 (lot# EN6198) without known complications.
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| 58 | 2021-03-18 | mouth numbness, swollen tongue |
Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, fin...
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Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, finger numbness. Benadryl was given at 1046.u
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| 58 | 2021-03-18 | mouth numbness, swollen tongue, mouth tingling |
Pt. c/o tongue swelling. Numbness and tingling. Vital signs: 2:10pm 135/105 82 17 O2 96% 2:25pm 12...
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Pt. c/o tongue swelling. Numbness and tingling. Vital signs: 2:10pm 135/105 82 17 O2 96% 2:25pm 125/100 75 16 O2 94%; 2:40pm 130/82 75 16. Given 20ml of Diphenhydramine by mouth @ 2:30pm.
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| 58 | 2021-03-18 | mouth numbness, lip swelling |
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog...
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hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
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| 58 | 2021-03-18 | mouth numbness |
tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, an...
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tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 03Feb2021 15:59 at single dose for covid-19 immunisation administered at state facility. Medical history included Asthma (diagnosed about 5 or 6 years ago, states she has probably had it all her life) and Fibromyalgia (diagnosed about 20 years ago). Historical vaccine includes Shingrix shot on an unspecified date, she did not feel well for a day, she felt sick but then it resolved it. The patient's concomitant medications includes pregabalin (LYRICA) at 250 mg (It is a 50mg capsule, she takes 100mg in the morning and 150mg in the evening) for Fibromyalgia; budesonide, formoterol fumarate (SYMBICORT) at 2x/day (two puffs twice a day) for Asthma and montelukast sodium (SINGULAIR) at 20 mg, 1x/day (once a day). The patient reported that she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. 45-60 minutes after, she felt the tip of her tongue, lips and part of her cheek become numb. She said this went away after 30 minutes. Consumer wants to know what reactions can she expect after she receives the 2nd dose, and if it would be worse than her reaction with the 1st dose. Asking if she should take Benadryl before the second dose. She is asking if she would have more of a problem. States she is an allergic person. She stayed at the facility for 30 minutes. Event occurred while she was driving, she thought if it got worse, she would go to the hospital but then it went away. The patient took covid vaccine for preventive action. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events resolved. Information on the lot/batch number has been requested.
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| 58 | 2021-03-19 | ringing in ears, ear discomfort, hearing loss |
Very loud worsening of Tinnitus that interfered with hearing and very weird feeling ears. I went to ...
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Very loud worsening of Tinnitus that interfered with hearing and very weird feeling ears. I went to the doctor and was prescribed Flonase, Sudafed, and an antihistamine. Using those improved the symptoms after about a week.
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| 58 | 2021-03-20 | mouth tingling |
lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Brea...
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lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Breath sound clear, no post oropharyngeal edema, no angioedema on exam. No urticaria or skin changes. Suspected anxiety vs. mild allergic reaction, offered Benadryl, which pt accepted, was given Benadryl and observed for 30 minutes, at whichpoint she felt symptoms had nearly resolved completely
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| 58 | 2021-03-21 | lip swelling, mouth tingling |
3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfiz...
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3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
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| 58 | 2021-03-21 | eye swelling, swelling around the eyes |
As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotc...
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As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotchy and my eyes started to swell. I took benedryl and applied a cool pack. Redness and swelling around mybeyes lasted for 2+ days. Still not feeling well and have scheduled a doctor appointment for tomorrow.
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| 58 | 2021-03-21 | visual impairment |
Sat down, grabbed phone and couldnt see it, told husband to get somebody, escorted to cot via wheelc...
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Sat down, grabbed phone and couldnt see it, told husband to get somebody, escorted to cot via wheelchair due to feeling light headed and nauseous. Pt continuously monitored until 10:40 when she was escorted out via wheelchair and accompanied by RN and patient husband.
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| 58 | 2021-03-21 | mouth numbness, swollen tongue |
Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness ...
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Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness hands
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| 58 | 2021-03-21 | double vision, vision blurred |
Third Nerve Palsy; vision was double; vision problems which was like little blurry; Myasthenia gravi...
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Third Nerve Palsy; vision was double; vision problems which was like little blurry; Myasthenia gravis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported), at the age of 58-year-old, as SINGLE DOSE for covid-19 immunisation. Medical history included thyroid disease and asthma. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 12Jan2021 and developed Covid symptoms and on 18Jan2021, the patient was tested positive, was sick from all and had fever (stopped at end). On an unspecified date, the patient stated she was just at the hospital on Tuesday, in emergency room and they told me that she should report possible side effects from the Covid vaccine. The patient have the Third Nerve Palsy they think this might be connected to the vaccine they are not sure. When paraphrased the concern, consumer stated, "They said I should just report that there was a reaction and they don't know if the Third Nerve Palsy is due to the vaccine or just something freak that I got." When probed if patient was a Health Care Professional, consumer stated, "I am not, I am a manager." The patient also added, "Can I give you the Path Gram, on the 9th I had my first shot on the 12Jan, I developed Covid symptoms and on 18Jan I was tested positive, I was sick from all and finally got tested on the 18 and was Positive and finally stopped my fever at end, I think may be 01Feb, and they told me to get my second shot I got my second shot on 05Feb and on 15 I started having vision problems which was like little blurry and I went to my eye doctor and they didn't think anything else he said that it could be something from Covid like what they called continuing symptoms but not having Covid, I don't know what the terminology is or it could have been from vaccine then that was the 15, the following Monday I went to my Primary because my vision was double at this point in my right eye and they thought it might be sinus related I had a CT done came back normal they told me that they thought it was Third nerve palsy and I had a MRI in the meantime they told me to go back to my Ophthalmologist which I did on Tuesday as soon as he see my he sent me to emergency room cause he thought it was an Aneurysm, so I was in the Emergency room being examined in hospital in (withheld) when I spoke to the Doctor they said I should advise Pfizer that they can't prove but it's vaccine related." When the patient was asked about teatment: she stated, "Well right now what they are doing is they had an had a MRI to be sure it was not Aneurysm or brain tumor which thank God came back negative and they did blood work so they are assuming it's third Nerve Palsy at this point but I have to see in 4 weeks it clears up or it could be Myasthenia gravis." The outcome of the events was unknown.
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| 58 | 2021-03-22 | taste impairment, mouth tingling |
I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was fr...
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I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was from the neck up. then I had a tingly tongue and a metallic taste in my mouth. it did NOT swell, it just didn't feel right. has resolved by today 03/23
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| 58 | 2021-03-22 | mouth tingling |
Patient had shortness of breath, nausea, dizziness, and their tongue tingled soon after receiving th...
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Patient had shortness of breath, nausea, dizziness, and their tongue tingled soon after receiving the Pfizer vaccine. EMT onsite evaluated patient and called 911. Ambulance Service arrived, evaluated the patient, and transported the patient to the hospital.
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| 58 | 2021-03-22 | vision blurred |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-03-22 | mouth numbness | tongue numbness |
| 58 | 2021-03-23 | taste disorder |
Patient received the Covid-19 vaccine. She reports symptoms of lightlessness, taste in mouth. Pt sta...
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Patient received the Covid-19 vaccine. She reports symptoms of lightlessness, taste in mouth. Pt stated she is unsure if she had a seizure since she has a hx of seizure disorders. Pt did take medications this morning. Pt does not have any facial swelling. Pt started feeling unwell at 11:02am Vitals: B/P: 110/74 HR: 110, 105, 100 02: 87 11:20: Vitals: B/P: 112/74 HR: 98, 86 02: 97 11:32am: BP: 116/76 HR: 86 02: 97 11:45am: B/P:112/72 02: 97 HR: 86 Pt stated she feels ok now, husband is here with pt and is driving her home. Pt aware to mention this to health care provider, pt verbalized understanding
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| 58 | 2021-03-23 | loss of taste, ringing in ears | ringing in the ears and lost of taste |
| 58 | 2021-03-24 | taste impairment |
Chemical taste in mouth was the first sign, then inability to swallow for approximately 1-2 minutes....
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Chemical taste in mouth was the first sign, then inability to swallow for approximately 1-2 minutes. Resolved by itself and no further problems.
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| 58 | 2021-03-24 | visual impairment |
I was hospitalized with visual disturbances which lasted about 30 minutes and transient aphasia that...
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I was hospitalized with visual disturbances which lasted about 30 minutes and transient aphasia that lasted about 1.5 hours and blood pressure of 190/85.
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| 58 | 2021-03-24 | toothache |
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ...
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Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
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| 58 | 2021-03-24 | mouth numbness |
Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: ...
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Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: @ 0815 TEAM ALERT was called to covid vaccine clinic. This RN arrived @ 0818 to find pt sitting in chair in observation room. Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10. 0818: VS: BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828: VS: BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842: VS: BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented. 0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS: BP 118/72. HR 63. O2 Sat 100%. 0857: Pt left covid vaccine clinic ambulatory in stable condition. COVID Vaccine Worksheet 1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes 2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No 3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? No 4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No Assessment: Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms. After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
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| 58 | 2021-03-24 | mouth numbness | Tongue numbness. Referred to EMS. No transport. |
| 58 | 2021-03-24 | swollen tongue | tongue swollen and irritated by my teeth on each side of my mouth |
| 58 | 2021-03-25 | ear pain | Fever 102+, headache, stomache ache, ear ache, body and muscle pain, skin hurt, chills, muscle pain |
| 58 | 2021-03-25 | ear pain |
Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on l...
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Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on left arm injection site
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| 58 | 2021-03-25 | feeling of choking, mouth tingling, mouth numbness |
Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my l...
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Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my lips, tongue, mouth and throat. My throat felt like it was closing or tightening and I had difficulty swallowing. I was administered Benadryl at the vaccine site and then transported by ambulance to the Hospital. There I was given an IV with peptide, steroid and benadryl. After a couple of hours, my symptoms began to improve and I was released. I continued to experience irritation of my tongue and mouth and a sore throat until the next day.
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| 58 | 2021-03-27 | pain in jaw |
Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st ...
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Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st day.
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| 58 | 2021-03-28 | loss of taste |
First dose was only pain at the injection site. During the 2nd dose injection, the needle became di...
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First dose was only pain at the injection site. During the 2nd dose injection, the needle became disattached from the syringe during the injection process. The needle stayed in my arm and had to be pulled out manually. There was no way to note how much of the vaccine was actually delivered. I am, however confident that I received enough of the dosage to cause me some uncomfortable side effects starting within 12 hours. I had a low grade fever, chills and a pretty significant headache that lasted about 18 hours. After that point, I took an alleve and the symptoms resolved within an hour. These are all typical side effects so I wasn't going to fill this form out, but I have noticed something unusual that I haven't seen much about. My taste is way off. I am now 5 days out from my 2nd vaccine and still nothing tastes right. Not bad or like anything specifically, it's just that nothing has any flavor. I can still smell just fine and can minimally taste my food but it just doesn't taste normal.
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| 58 | 2021-03-28 | swelling of eyelid, mouth numbness |
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and chee...
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Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip. Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.
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| 58 | 2021-03-28 | lip swelling |
pt states that her ears started itching and became red. She noticed her back, legs, and arms were r...
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pt states that her ears started itching and became red. She noticed her back, legs, and arms were red and very itchy. She says her skins is raised like a rash. Her voice became strange and she lips were swollen. She went to bed and when she got up her lips were more swollen. She took Benadryl for her symptoms and went back to bed. She says she has some itching but feels like she seems to be improving.
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| 58 | 2021-03-30 | eye bleeding |
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ...
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Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
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| 58 | 2021-04-06 | vision blurred |
Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went t...
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Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
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| 58 | 2021-04-21 | ear discomfort, ringing in ears |
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve...
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inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
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| 58 | 2021-04-24 | swollen tongue |
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my...
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She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
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| 58 | 2021-04-24 | ringing in ears, ear pain |
Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Moment...
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Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
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| 58 | 2021-04-24 | mouth numbness |
numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; ...
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numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left, at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it, moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-04-29 | hearing loss |
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ...
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This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
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| 58 | 2021-04-29 | eye pain |
Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until appro...
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Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until approx 9pm and then went away. Sat 4/24/21 woke up with Sore L. Arm at site of Vaccine, but felt better. Sun. 4/25/21 woke up at 7:30am and didn't feel well, nausea, chills, needed to lay down, about 8:00am severe Headache at my Sinuses, Behind my Eyes, Forehead, and Back of Head at Base of Neck through 10pm. I took Speedy Release Tylenol, 3 hrs later Headache was returning I took 2 Ibuprofen and slept. Slept most of the day until 9pm when I felt I could tolerate Chicken Noodle Soup. I woke up Mon. 4/26/21 w/mild Headache just behind my Eyes.
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| 58 | 2021-05-02 | ear pain |
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge...
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1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
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| 58 | 2021-05-10 | lip swelling |
Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips ...
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Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering. Follow-up information requested.
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| 59 | 2021-01-01 | loss of taste |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-03 | mouth numbness |
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (a...
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I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
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| 59 | 2021-01-03 | tongue itchiness | TONGUE ITCHING AT 0940; RECEIVED VACCINE AT 0721. REFERRED HER TO HER PCP. |
| 59 | 2021-01-04 | ringing in ears |
Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pl...
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Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pleasant. Within first 24 hours after administration patient had regular side effects including headache, fever (99.8) , and chills that disappeared after 36-48 hours.
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| 59 | 2021-01-04 | smell distorsion |
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh...
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Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-01-04 | bloodshot eyes | Woke up with redness to the left eye. |
| 59 | 2021-01-05 | vision blurred | Extreme Dizziness, Blurry Vision, Near fainting and Nausea |
| 59 | 2021-01-05 | vision blurred |
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness...
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Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
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| 59 | 2021-01-06 | eye swelling |
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the...
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Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
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| 59 | 2021-01-06 | mouth itchiness |
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho...
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Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
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| 59 | 2021-01-06 | ringing in ears |
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also r...
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Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
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| 59 | 2021-01-06 | lip swelling |
Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelli...
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Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.
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| 59 | 2021-01-07 | mouth swelling, lip swelling |
Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind ...
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Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind of swollen up; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had the COVID shot on Tuesday (29Dec2020) and thinks her mouth is kind of swollen up. Her bottom lip is not crooked or nothing like it but inside it is kind of a little swelled. The patient started experiencing the adverse events in the morning of 31Dec2020. No treatment was administered for the events, and the patient was advised to contact primary healthcare professional. The outcome of the events was unknown.
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| 59 | 2021-01-07 | dry mouth |
Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has li...
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Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has lingering post nasal drainage.
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| 59 | 2021-01-07 | mouth tingling |
Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close mon...
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Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close monitoring Allergies: Codeine, Latex, Iodine Contrast, Hydrochlorothiazide. No known food allergies, but consumed two foods new to her (yogurt parfait and Gatorade Zero) just prior to injection
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| 59 | 2021-01-07 | mouth tingling, mouth numbness |
Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a c...
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Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 04Jan2021 14:30 at single dose at left arm for COVID-19 immunization. There was no medical history reported. Concomitant medication included pravastatin, levothyroxine, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium, glucose oxidase, lactoferrin, lactoperoxidase, lysozyme, sodium fluorophosphate (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME;SODIUM FLUOROPHOSPHATE]). On 04Jan2021 14:45, within 15 min observation period, the patient experienced tingling in mouth, numb tongue and lips. No throat swelling. The patient was given 25mg diphenhydramine. Therapeutic measures were taken as a result of tingling in mouth, numb tongue and lips. The outcome of the event was recovered in Jan2021.
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| 59 | 2021-01-07 | mouth tingling | tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called |
| 59 | 2021-01-07 | mouth tingling | tingling tounge and flushed, monitored until resolution, |
| 59 | 2021-01-08 | mouth tingling |
patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling...
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patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling. Onset @ 1235, 8 minutes after injection. Lasted for ~ 10 mins then subsided. No rash/itch. Agree with assessment unlikely to allergic rxn
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| 59 | 2021-01-10 | lip swelling, swelling of eyelid |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-11 | vision blurred |
1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke f...
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1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke feeling same. I took routine vitamins and 2 extra strength Tylenol. Symptoms lasted all day with difficulty walking due to the dizziness. Also had difficulty focusing, blurry vision. 1/6/2021 still a little lightheaded just a little dizzy. Headache ( I have routine headaches). lightheaded and dizziness decreased with each day.
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| 59 | 2021-01-11 | vision blurred |
numbness in right fingers along with tingling. moved to back of neck and side of face. right side ...
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numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-11 | loss of smell, loss of taste |
tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Cov...
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tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use.
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| 59 | 2021-01-12 | dry mouth |
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter...
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1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
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| 59 | 2021-01-13 | swollen tongue |
About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue s...
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About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and then transported down to the emergency department. Upon arrival to the ED, she felt markedly improved with no symptoms other than some mild nausea. Patient was treated with steroids and ondansetron.
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| 59 | 2021-01-13 | eye swelling, eye pain |
Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was mor...
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Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was more prominent, rinsed eyes with cold water multiple times. Swelling still exists 1/14/2021 at 1315, (time of typing this information). Seeing slight improvement.
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| 59 | 2021-01-13 | ear discomfort |
Patient began to experience neck pain on the same side she received her injection along with tightne...
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Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
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| 59 | 2021-01-13 | lip swelling |
The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injec...
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The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injection. She denies any other symptoms. Denies itching or pain of area. Denies swelling of tongue or throat. Denies shortness of breath. Was seen by her PCP and symptoms were attributed to angioedema due to ACEi medication.
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| 59 | 2021-01-13 | eye pain |
wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; h...
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wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
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| 59 | 2021-01-14 | feeling of choking |
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my...
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About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt when I had my reaction to Gadolinium. I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve. I had brought my Epinephrine pen with me. About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated, I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving. I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing. The plan was to complete treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these symptoms increased, ( I could still breath adequately and vital signs were still OK. It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
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| 59 | 2021-01-15 | mouth tingling, lip swelling |
Started 5am on 1/16. Upper lip felt tingly. Applied ice and fell asleep. Awoke at 9am to extremely s...
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Started 5am on 1/16. Upper lip felt tingly. Applied ice and fell asleep. Awoke at 9am to extremely swollen upper lip. Took Benadryl 25mg at 9:15 am and 1:15 pm. At 6:30 pm, has improved but not completely yet.
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| 59 | 2021-01-16 | loss of smell, loss of taste |
About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night...
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About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night, had mild sweats and chills and moderately severe body pain, especially in legs and back. The next morning had no sense of taste or smell. Body pain and loss of taste improved over the day. ,
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| 59 | 2021-01-19 | lip swelling, eye discomfort |
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut...
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Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
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| 59 | 2021-01-19 | mouth tingling |
Person receiving the vaccine developed a tingling in her mouth. Not short of breath or itchy, no hiv...
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Person receiving the vaccine developed a tingling in her mouth. Not short of breath or itchy, no hives. Vital signs 156/90, Pulse 72, SPO2 97. Gave her water and candy, sat her in recliner with feet up. She remained with us for over 30 minutes. Felt better after water. Vital signs before leaving were 147/90, pulse 73, SPO2 97
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| 59 | 2021-01-19 | eye pain, dry eye | TEMPERATURE OF 100.7, BODY ACHES, EYES STINGING AND DRY, HEADACHE |
| 59 | 2021-01-20 | ear pain |
Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I no...
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Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I noted tingling and a "tight" feeling on the right side of my face. I have had bells palsy before and if felt the exact same way. I noted drooping of the right side of my mouth, stabbing pain in my right ear. This lasted for 24 hours, currently, slight numbness remains at corner of right side of mouth and occasional stabbing pain right ear.
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| 59 | 2021-01-21 | mouth numbness, mouth tingling |
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting...
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Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
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| 59 | 2021-01-23 | lip swelling |
1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--ve...
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1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--very sleepy; bad balance--small steps and holding wall/furniture; lips swollen; slow cognition
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| 59 | 2021-01-23 | lip swelling, swollen tongue | Swollen bottom Lip, tongue, prickly skin, burnining nostril, headache, fatigue |
| 59 | 2021-01-24 | swollen tongue, eye swelling |
Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purch...
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Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purchased Benadryl. The swelling started to diminish after about 4 hours, but tingling and slight numbness continued for about 3 days.
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| 59 | 2021-01-24 | tongue disorder |
hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue th...
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hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue thickness. Rapid response team notified. Epinephrine given and patient transported to ER
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| 59 | 2021-01-25 | taste impairment | Metal taste in mouth directly after administration of vaccine, no airway changes. |
| 59 | 2021-01-25 | vision blurred |
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ...
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Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 59 | 2021-01-25 | ear discomfort |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-26 | gaze palsy |
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,...
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14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
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| 59 | 2021-01-26 | mouth numbness, lip swelling, mouth tingling |
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i...
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My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
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| 59 | 2021-01-26 | swollen tongue |
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al...
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Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
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| 59 | 2021-01-27 | vision blurred | bruising to site, painful, next day very tired with blurry vision, aching pain |
| 59 | 2021-01-27 | mouth numbness |
numbness in my mouth and around my lips. Numb for 3 days now experiencing numbness on left side of f...
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numbness in my mouth and around my lips. Numb for 3 days now experiencing numbness on left side of face, felt like druelling sensation
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| 59 | 2021-01-28 | taste disorder, smell distorsion, extreme sound sensitivity |
Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headach...
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Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headache, heightened smell, taste, and hearing
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| 59 | 2021-01-28 | inability to speak |
Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever...
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Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever and tiredness
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| 59 | 2021-01-28 | oropharyngeal discomfort |
The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pal...
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The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pale and blood pressure was 205/198 along with tachycardia. Spent hours in E.R.
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| 59 | 2021-01-28 | mouth pain |
Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside...
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Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-29 | oropharyngeal discomfort |
Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today...
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Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today in left deltoid. Pt expressed "scratchy throat" and strange feeling radiating from shoulder to upper rhomboid muscles after 5 minutes. Gave patient drink of ice water with Diphenhydramine 25mg po (Lot 502605 exp 10/31/2021). After 10 minutes reassessed and still experiencing little improvement. Gave second dose Diphenhydramine 25mg po, and observed for next 30 minutes. Patient expressed feeling better and not so scratchy in her throat. Escorted to vehicle after stating that she felt well enough to drive home. Recommended she f/u with her physician and may need to pre-medicate with diphenhydramine 25mg prior to booster.
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| 59 | 2021-01-30 | eye itchiness |
Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased a...
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Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased and B/P 180/104. H/R 120. Discharged 170/98 B/P HR 111 bpm. Discharged with her husband driving. Advised to follow up with hospital and to follow up with her PCP before anymore immunizations.
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| 59 | 2021-02-01 | ear pain |
Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from wor...
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Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to and tested neg for COVID and Flu. I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
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| 59 | 2021-02-01 | taste disorder |
I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I start...
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I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I started feeling crappy. I had no taste and smell, very fatigued and slept all the time so I went and got tested for COVID. While there my O2 level was 89 so I was given a steroid injection and was sent home with an antibiotic and was off for the 14 day quarantining and went back to work
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| 59 | 2021-02-01 | smell distorsion, taste disorder |
Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs...
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Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs but only lasted 1 second. Chills a few hours later that lasted about 4 hours. Next morning felt stomach sick. Couldn't eat or drink anything but water. Barely make it to the bathroom because joints hurt and just felt sick. Tried toast and coffee, tasted terrible. I am a very strong coffee drinker. Haven't been able to drink it since vaccination because nothing tastes or smells the same. Went to primary yesterday because haven't been able to sleep. Told him weird taste and smell, can't eat anything and I feel like my muscle is very weak. Trouble getting in car yesterday for work.
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| 59 | 2021-02-02 | tunnel vision |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-05 | eye irritation |
PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA...
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PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA AND EYES BURNING.
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| 59 | 2021-02-06 | sensitivity to light | Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm. |
| 59 | 2021-02-07 | mouth numbness |
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo...
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Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
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| 59 | 2021-02-07 | vision blurred |
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry....
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Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
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| 59 | 2021-02-08 | eye floaters |
Approximately 2 hours after vaccine, I started seeing flashes of light in my left eye, which continu...
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Approximately 2 hours after vaccine, I started seeing flashes of light in my left eye, which continued and became worse through the evening with an increase of floaters in my left eye. This morning I only saw the lights a couple of times but more floaters.
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| 59 | 2021-02-08 | ringing in ears, vision blurred, loss of taste |
Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 day...
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Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 days. Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy. On February 8th, these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy, intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm. Loss of taste again.
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| 59 | 2021-02-08 | mouth tingling | Tingling of tongue, facial itching. |
| 59 | 2021-02-10 | eye pain, extreme sound sensitivity, vision blurred, thirst, ringing in ears, taste disorder |
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug...
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7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
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| 59 | 2021-02-11 | eye bleeding | Headache then right eye blood vessels bursted |
| 59 | 2021-02-11 | mouth pain, swollen tongue, burning mouth syndrome |
Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores ...
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Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores (red/swollen/sore) on both sides and tip of tongue + a fizzing feeling on top of the tongue starting about 10 days after injection. Fizzing feeling on roof of mouth (opposite side to previous sore) at same time as tongue sores. At this date, the roof of mouth and cheek sores are healed, but the tongue sores have spread and make eating and talking challenging. Additional side effects - Increased asthma for 7 days after injection - treated with Albuterol and Dulera. Tiredness and chills within first 2 days of injection Sore upper arm for 2 days, followed by continued soreness in elbow.
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| 59 | 2021-02-11 | eye itchiness, swelling of eyelid | left eyelid swollen, itchy and a little weepy |
| 59 | 2021-02-15 | taste disorder, taste impairment |
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ...
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Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
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| 59 | 2021-02-15 | eye twitching | Left eye twitching |
| 59 | 2021-02-17 | vision blurred |
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu...
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Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
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| 59 | 2021-02-17 | lip swelling, mouth numbness |
This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (no...
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This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 05Feb2021 08:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included colorectal cancer and thyroid cancer. She had allergies to sulfur. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient experienced her lips felt swollen and numb for about one hour after the dose was administered (non-serious) on 05Feb2021. No treatment was given. The outcome of events was recovered on unspecified date in Feb2021. Information on the lot/batch number has been requested.
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| 59 | 2021-02-17 | loss of taste, loss of smell |
This is a spontaneous report from a contactable other health professional. A 59-year-old patient re...
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This is a spontaneous report from a contactable other health professional. A 59-year-old patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration in the left arm on 22Jan2021 at 17:00 at 59-years-old at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included pneumothorax from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (Prior to vaccination). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate (PRISTIQ), meloxicam (MANUFACTURER UNKNOWN); taken for an unspecified indication from an unspecified date to an unspecified date (received within 2 weeks of vaccination). The patient previously took diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate, salmeterol xinafoate (ADVAIR diskus) and experienced allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown) for COVID-19 immunization on an unknown date. On 23Jan2021 at 04:00, the patient experienced: temp 101.7 which held for 28 hrs, then 100.7 for 24 hrs, now at 99.4 (non-serious), severe back pain (non-serious), severe joint swelling in hands (non-serious), severe headache (non-serious), severe body aches and pain (non-serious), right foot felt like bones were broken when walking (non-serious), coughing (non-serious), increased phlegm production (non-serious), loss of taste (non-serious), loss of smell (non-serious); in which no treatment was received. The patient, however, went to a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included temperature: 100.7 in Jan2021 for 24 hrs, temperature: 101.7 on 23Jan2021 held for 28 hrs, temperature: 99.4 on 26Jan2021. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 59 | 2021-02-18 | mouth numbness, taste disorder |
Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in t...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in the mouth, then throat became numb and I could not swallow unless I really forced it. I had to drink to be able to swallow. Again had to really try before I could. Then roof of mouth, back of throat and back of tongue felt number as if I had novocaine. The lack of swallow lasted about 10 minutes of forced swallowing. The numbness continued for about 2 hours but I was able to do everything. The numbness was more of an annoyance.
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| 59 | 2021-02-19 | dry mouth, vision blurred |
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,...
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On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
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| 59 | 2021-02-21 | mouth pain, burning mouth syndrome |
Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or ...
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Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or three sores, and they lasted about 5 or 6 days.) I share this because I got my second dose 2/17/21 batch EL9266 in left arm and again two days out got sores on my lip and tongue (total of 2 sores that hurt). The one on my tongue has made it hard to swallow, because it is far back on my tongue. I have used a peroxide product to lesson the pain. I am 5 days out from my second vaccine, and the sores are not getting worse and I hope they lesson and go away as the first batch did after about 6 days.
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| 59 | 2021-02-22 | loss of smell, smell distorsion |
02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolv...
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02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
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| 59 | 2021-02-24 | swollen tongue |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-25 | taste impairment |
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af...
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Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
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| 59 | 2021-03-01 | swelling of eyelid, eye swelling | Body aches, fever (101.5), swollen eye lids and beneath eyes, headache, upper back aches, chills |
| 59 | 2021-03-01 | ear swelling, lip itchiness, lip swelling |
approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my le...
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approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my left cheek and my upper lip swelled. The swelling stayed itchy for about 3 hours
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| 59 | 2021-03-02 | mouth numbness |
20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Pat...
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20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Patient was given 50mg of PO diphenhydramine and was monitored for 60 min. Refused call to 911. Flushing and warmth had abated and left clinic under own volition.
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| 59 | 2021-03-02 | ringing in ears | Pain, swollen gland, flu, chills, tinnitus, fatigue |
| 59 | 2021-03-03 | ear pain, lip swelling, pain in jaw |
right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it wa...
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right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen; felt sick similar to a sinus infection/pressure in front of head, jaw, right ear/sinus pressure/pressure in nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure; dizzy on and off/Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus problems, allergy, allergy to cow's milk, TMJ (she had her wisdom teeth she was having issues on the right side; after they pulled it out she was fine), and wisdom teeth pulled out at the age of 57 or 58. Concomitant medication included ascorbic acid, biotin, folic acid, iron, manganese, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM FRUITY CHEWABLES). The patient previously took keflex and was allergic to it. The patient received her first dose of COVID-19 vaccine on 19Jan2021. She was okay from Tuesday to Thursday. On Friday (22Jan2021), the patient reported to have felt sick similar to a sinus infection, there were pressure in front of head, jaw, and right ear and was dizzy on and off for a long period. She had a sinus pressure/pressure in her nose and felt like she had a bad sinus infection in whole head. She is not saying she had a sinus infection, but that's what she experienced after receiving the shot. Her right ear was aching, head was ache, and jaw was also aching/throbbing on unspecified dates. The patient mentioned that she had swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen on 07Feb2021 but it went away today (08Feb2021). It was actually her neighbor that noticed the swelling and said it was on the bottom of lip chin area, it also felt hard when touching it. She called her primary care doctor following the events. At first, she did not want to provide these to her primary care, she did not have high blood pressure, high cholesterol or anything, but she did have bad sinuses. She took an antibiotic for sinus and pressure and her doctor told her that these could be side effects of the COVID vaccine as it causes dizziness and pressure. The dizziness must have been from the pressure since it was in her ear, cheek bones, and right ear was throbbing. It took her one month to come back to her normal self. The patient is scheduled to receive the next shot on 09Feb2021 and asked if she need to get the next shot or should she wait another week. The patient recovered from events "felt sick similar to a sinus infection/pressure in front of head, jaw, and right ear/sinus pressure/pressure in her nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure" and dizzy on and off/dizziness on 06Feb2021; recovered from event swelling of bottom lip on 08Feb2021; while unknown outcome for the remaining events. Information on the lot/batch number has been requested.
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| 59 | 2021-03-06 | ringing in ears |
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, acros...
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Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body. Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
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| 59 | 2021-03-06 | mouth tingling |
Tingling in lips and tongue. Scratchiness in neck and facial area (right side). Vitals within normal...
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Tingling in lips and tongue. Scratchiness in neck and facial area (right side). Vitals within normal limits; Benadryl 50 mg PO given.
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| 59 | 2021-03-06 | mouth tingling | Tingling in upper lip, nose, hairline and right arm. Evaluated by medics-cleared |
| 59 | 2021-03-07 | mouth tingling |
5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. ...
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5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. EKG NSR. Pt DC home stable condition 11:42
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| 59 | 2021-03-07 | swollen tongue |
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ...
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Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
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| 59 | 2021-03-10 | oropharyngeal discomfort |
I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body ...
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I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body aches, joint aches, headache, fatigue, and nausea. The next night I started vomiting. I felt like I had the flu. These symptoms persisted 3-4 days. The sore throat lasted maybe a week or more. No fever at any time. Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received. The arm soreness awakened me at night if I rolled over. FYI: I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.
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| 59 | 2021-03-10 | eye pain |
I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus wh...
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I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus which helped. As the day went by, I began to have body aches, chills, joint pain, nausea. I took my temp at bedtime, it was 101.9. On Monday, things were much worse. My temp was 102.4 upon awakening & the pain level for my head was excruciating. Again, Taking Tylenol Sinus helped w/the headache & fever, not so much for the rest. On Tuesday, I woke & took my temp, it was normal. It is now Thursday, 3/11 & although I have no fever, it still feels as though I have one. Regular Tylenol helps but the head ache, body aches & fatigue remain.
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| 59 | 2021-03-10 | oropharyngeal discomfort |
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre...
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Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
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| 59 | 2021-03-11 | lip swelling |
9 hours after injection, injection site started to swell significantly. after putting a cool towel a...
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9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack, started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
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| 59 | 2021-03-11 | sensitivity to light |
Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that e...
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Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that escalated to finally resulting in shingles outbreak. Week 3- horrible rash on left torso from t-spine to front of abdomen and excruciating pain. Week 8 - horrible torso pain continues with rash fading. I am currently at week at time of this report.
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| 59 | 2021-03-12 | mouth tingling, lip itchiness |
Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lip...
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Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lips. Treated with Benadryl 25mg x 2 doses. Duration of 1 day.
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| 59 | 2021-03-12 | taste impairment | Metallic Taste immediately after injection. Felt a bit wobbly. |
| 59 | 2021-03-14 | tongue discomfort |
1050: Pt in waiting lot after receiving 2nd dose of Pfizer vaccine. Reported to attendant sensation...
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1050: Pt in waiting lot after receiving 2nd dose of Pfizer vaccine. Reported to attendant sensation of throat tightening. RN and NG medic responded to vehicle. Pt calm, talking, no appearance of distress. States "feels like my mask is too tight". Also states tongue feels different. Denies itching, denies SOB. 1054: VS stable. 1057: Med Officer contacted. Advised Benadryl 25mg po per s.o./ med administered. MD also instructed pt to take home med of ProAir on arrival home and be sure to take Singulair tonight. Pt advised. No further progression of symptoms. Pt left lot @ 1115. RN f/u with ph call @ 1335. Pt home, reported symptoms have resolved. No further complaints.
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| 59 | 2021-03-14 | lacrimation increased, eye swelling, eye itchiness, bloodshot eyes |
Eyes became extremely itchy, red, watering, swollen. I also began sneezing and runny nose. I took ...
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Eyes became extremely itchy, red, watering, swollen. I also began sneezing and runny nose. I took a Benedryl and within 20 minutes was feeling much better. I continued the Benedryl every four hours through the night (set alarms) and was fine in the morning. Reaction started in the afternoon (1:00 p.m.). Took Benedryl at 3:00 p.m., 7:00 p.m., 11:00 p.m., 4:00 a.m. (time changed). I did not need any more at 8:00 a.m.
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| 59 | 2021-03-14 | mouth tingling |
I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy sho...
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I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy shots were missed a year or so ago. Burning and tingling feeling in legs, torso, neck basically where clothes touches or rubs. Some tingling sensation on tongue as well. I stayed after 20 minutes after the vaccine because of I have allergies. After I left and got into my car to drive away I started having the burning feeling in my legs, torso and tingling in lips and tongue. I work for the ED group, so I drove over and stayed by the entrance until I felt like it was not getting any worse. I waited for about an hour. I though the burning sensation would go away, but it has not. I called my allergist and he advised I should contact you and report via this source.
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| 59 | 2021-03-14 | swollen tongue | Tongue Swelling - took benadryl |
| 59 | 2021-03-14 | swelling of eyelid |
left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthca...
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left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581 and expiry date unknown), via an unspecified route of administration in the left arm on 10Feb2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medications included vitamin D NOS and vitamin C [ascorbic acid]. Patient experienced left eyelid swollen, itchy, and a little weepy on 10Feb2021 18:30. Patient was recovering from the events. No treatment was received for the adverse events. This case was reported as non-serious.
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| 59 | 2021-03-15 | swollen tongue |
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar...
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Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
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| 59 | 2021-03-17 | mouth numbness |
Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throa...
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Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throat every 10 minutes for about 45 minutes.
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| 59 | 2021-03-17 | lip swelling, vision blurred |
swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/depart...
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swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
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| 59 | 2021-03-18 | mouth numbness |
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar...
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(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
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| 59 | 2021-03-18 | taste impairment |
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my...
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About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
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| 59 | 2021-03-18 | eye swelling |
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on e...
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Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so. And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
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| 59 | 2021-03-18 | dry eye |
Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. i...
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Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. it started off as becoming very tight, then the tingling. it has been over 24 hours and still sum tingling in the check bone and chin area.
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| 59 | 2021-03-18 | loss of smell, loss of taste |
She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold...
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She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold; She also had a fever of 99.5; chills; sweats; she had lost smell and taste; she had lost smell and taste; That night she could not lift her arm. It was sore at first; That night she could not lift her arm. It was sore at first/Then she could not lift her arm; tired/she felt extremely tired; terrible left leg pain; leg cramps/more so in the left leg and then it turned into both legs/sporadic leg cramps; full body achiness; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported for herself that a 59-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Jan2021 (at the age of 59-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing prophylactic health. Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81mg; calcium/colecalciferol (CALCIUM +D3) at 600mg; ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+); colecalciferol (D3) at 200 units and elderberry gummies with vitamin c and zinc. All are ongoing and taken for prophylactic health. The patient had her first COVID Vaccine dose on 09Jan2021. She thought she was getting a reaction but ended up testing positive for COVID. She was tested on 13Jan2021 and it came back positive the next day 14Jan2021. She had questions about when and if she should get the second dose. She was referred to speak with her doctor and Pfizer does not have information for that. She got her first dose on 09Jan2021. That afternoon (09Jan2021) her daughter came home, and she had lost smell and taste. That night she could not lift her arm. It was sore at first. She was laying down and her husband asked if she needed anything, and she said no. Then she could not lift her arm. She was sure that was from the vaccine. That lasted until 10Jan2021 and then she was fine and has recovered completely. That same day on 09Jan2021, she felt extremely tired. That lasted about two weeks from the COVID. On 11Jan2021 that Monday, she had also felt like she was getting a cold, but she was not even really stuffy. She also had a fever of 99.5. The chills were setting in even without a fever. She was got, had chills and sweats. That night she went to bed and woke up about an hour later and had terrible left leg pain. Her doctor wanted her to get tested in case it was COVID. She had called him that Monday she thinks, 11Jan2021. He wanted her to go to the ER, not somewhere private, in case she did have COVID, but she did not want to go. She had the leg cramps for 3 days, more so in the left leg and then it turned into both legs. She also had her legs checked out and was negative for any DVTs. It was 3 days of sporadic leg cramps. They were so bad and mainly on her left side. It then turned into full body achiness after that. Caller says overall she was fine. The outcome of the events smell loss, taste loss, pain in arm, mobility decreased recovered on 10Jan2021, all other events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
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| 59 | 2021-03-18 | mouth tingling, lip swelling |
Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Withi...
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Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Within approximately 20 minutes the patient's swelling began to subside. Patient felt better and tongue was no longer tingling.
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| 59 | 2021-03-18 | mouth numbness, ringing in ears |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-19 | ringing in ears |
Approximately 2days after 2nd day of Pfizer I fe leopard a white noise sound in my ears . Went to EN...
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Approximately 2days after 2nd day of Pfizer I fe leopard a white noise sound in my ears . Went to ENT and he said it is Tinnitus. I have never had this before and it has been persistent since I received vaccination
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| 59 | 2021-03-19 | taste disorder, taste impairment, lip swelling |
I woke up on 3-19-2021, about 48 hrs after the vaccine, with swollen lips. They also have a light me...
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I woke up on 3-19-2021, about 48 hrs after the vaccine, with swollen lips. They also have a light metallic taste. My sense of taste seems to be slightly affected. This is the reaction I have had in the past to antibiotics I am allergic to.
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| 59 | 2021-03-19 | bloodshot eyes | sever loss of energy. bloodshot eyes |
| 59 | 2021-03-20 | vision blurred, mouth tingling, ringing in ears |
Ringing in my ears since a day after I got the shot , Have had the condition previously but this has...
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Ringing in my ears since a day after I got the shot , Have had the condition previously but this has been exacerbated significantly since the vaccine. Sensation in tip of my tongue. Left eye feels like it is a bit burry . Hands and feet very cold . Has gotten better after the 5th day. Was tired for 5 days after vaccine.
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| 59 | 2021-03-20 | taste impairment |
headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a...
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headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:40 (Batch/Lot Number: EL9261) (at 59-year-old) as single dose for COVID-19 immunization. Medical history included Hypertension, Gout, Allergy. She clarified that she is allergic to NSAIDS and as well has environmental and food allergies. She clarifies that her Allergies do change from time to time, she is allergic to fragrances. Wheat bothered her before, but not anymore, thats what she meant by her allergies changes. Concomitant medications was not reported. She did not take any NSAIDS because they made her wheeze. She only had her regular medication that she takes on routine schedule. The patient previously took ibuprofen and allergy. She is Allergic to ibuprofen and had an asthmatic cough after it. The patient had first dose of the Pfizer covid vaccine a week ago Thursday, she has a question. She had that dose, and when she had the injection was fine, she did have a metallic taste in mouth (04Feb2021) but it was no issue. Then she woke up coughing on Friday (05Feb2021) and Saturday (06Feb2021), it was like an asthmatic feeling, she will feel it time to time when having an allergy to something. She had headache on Sunday (07Feb2021). She didnt know if that was an indication to a problem with the vaccine. She wanted to know if it was safe to take the second dose. It was clarified that the metallic taste started 10 minutes after the injections. The Asthmatic Cough started on Friday 05Feb2021, she woke up coughing. She clarified that the metallic taste only last just up to that afternoon. The asthmatic cough subsided Saturday. She experienced a lot of coughing on Friday, then a little on Saturday and that was last day. She was just concerned about it, she did not want it to get worse. She does not normally have metallic taste in her mouth, so she thought it could be related but she really doesn't know. She didn't know if the asthmatic cough is related, it could even be a coincidence, she hasn't experienced something like this in a year. She just wants to know if she should get the second dose. It stated that her second dose is schedule for 25Feb2021 at 11:40AM. The outcome of the event Taste metallic/ tongue felt metallic was recovered on 04Feb2021, Asthmatic Cough was recovered on 06Feb2021, and headache was unknown.
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| 59 | 2021-03-21 | swollen tongue |
On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows an...
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On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows and underside of forearms and upper left thigh. The rash got worse each day spreading all over my body causing me to seek medical treatment first with primary doctor who gave me prednisone pack and injection and then my local emergency room (twice) due to swelling of throat and tongue. I was given prednisone IV treatment and sent home with a high dose of medication for inflammation and hydroxyzine for itch and famotidine for stomach upset. My doctor got me in to see immunologist for tests and treatment. That doctor took blood and diagnosed me as having a moderate to severe delayed allergic reaction post covid vaccination. My liver had elevated levels of bili-rubin my white blood count was over 16,000 and my skin was cover in red, itchy hives and rash from head to bottoms of my feet for over ten days. I was very sick and miserable.
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| 59 | 2021-03-21 | lip swelling |
On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to fe...
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On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to feel a lump in my throat and developed large itchy hives all over my body. My lips began to swell up.
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| 59 | 2021-03-22 | double vision, vision blurred | Double vision x 4 days, continued blurred vision |
| 59 | 2021-03-22 | oropharyngeal discomfort |
Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported ...
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Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported mouth felt 'weird' and throat felt 'swollen' although no difficulty swallowing was reported. Assessed by provider Benadryl PO administered. After 20 minutes patient reported symptoms had resolved. Discharged to home with husband.
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| 59 | 2021-03-23 | thirst |
16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. ...
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16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. I asked to go outside and was told no. I moved from back to the front as i felt cold and was swearing. It was sift chsnge and the staff was huddled in a corner and i called for help.2x before taking off my mask amd callinf a thried time. By this point i felt like vomiting and nedded immediate water. The thirst was intrnse. The University of Arizona didn't have anything for me to throw-up into except a half full used large janitorial garbage can. I was given water and that really helped the thirst and nausea. The nurse came and put a monitor on my finger and immediately took me to a back area where rhe cold sweat and chills now covered my whole body and the thirst returned. Tje nurse took my vitals and i remember my heartbeat reading in the 30s and had a very low blood pressure. No one ever experienced what was happening and i asked if i was going to die. The only thing they had to lie down on was an army cot 6" off rhe ground. I wanted to lie down so badly buy it had no sheets, pillow or anything. With all the money they get from the feds they should be able to afford a gurney. I was never told the truth about what had happened to me. I was let go with a very low heart rate of 51. My normal is 68 to 78. No follow up instructions.
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| 59 | 2021-03-23 | mouth tingling, mouth numbness |
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing...
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I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days. Now I'm afraid to get my second shot due April 3rd.
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| 59 | 2021-03-24 | toothache, ear pain, ringing in ears |
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
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| 59 | 2021-03-24 | lip swelling |
Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon a...
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Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon after assessment. Pt refused transport to hospital.
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| 59 | 2021-03-25 | mouth tingling |
1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25m...
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1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25mg Po Benadryl to be given. Patient took Benadryl and refused water. 1110: Patient checked on by EMS on Duty with no changes. 1120: No changes to mouth noted still for patient. 1130: Still no changes, EMS on duty cleared patient for discharge home after 30 minutes of observation. Informed patient to seek immediate medical attention if symptoms should worsen. Patient communicated understanding.
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| 59 | 2021-03-25 | ringing in ears |
I noticed tinnitus in my left ear within 2 hours of receiving the vaccine in my left arm. Today, on...
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I noticed tinnitus in my left ear within 2 hours of receiving the vaccine in my left arm. Today, one week later, it continues. It is a high pitched ringing in my left ear. This is not normal for me at all.
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| 59 | 2021-03-26 | taste impairment |
3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light heade...
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3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light headed. Got chills. Hot & cold nauseated . It?s three days later I?m still very tired. Headaches , throats feels swollen , glands swollen. I feel like I got the flu! When is this going to end ?
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| 59 | 2021-03-26 | double vision |
Extensive dural venous sinus thrombosis, SAH, acute ischemic thalamic infarct. Headache, lethargy, d...
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Extensive dural venous sinus thrombosis, SAH, acute ischemic thalamic infarct. Headache, lethargy, diplopia, right arm weakness
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| 59 | 2021-03-26 | ringing in ears | Ringing in left ear. New. Never had before in either ear. |
| 59 | 2021-03-26 | eye movement disorder, swollen tongue, visual impairment |
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif...
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Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
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| 59 | 2021-03-26 | mouth tingling | palpitations, tingling over lips, rash |
| 59 | 2021-03-27 | bloodshot eyes, eye pain |
High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Bo...
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High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Body aches Joints hurt Left eye became bloodshot and hurt Cold sores inside and outside of mout
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| 59 | 2021-03-27 | swollen tongue | SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE, FAST HEART RATE, TINGLING IN FACE |
| 59 | 2021-03-28 | vision blurred |
Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in ...
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Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in head, memory problems, joint pain, right eye not focusing Have seen my primary, rheumatologist- received injection of steroid and put on oral steroids, chiropractor nerve stimulation, adjustment. Waiting to see a neurologist
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| 59 | 2021-03-28 | lip swelling |
Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-P...
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Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-Pen (branded generic form) was administered in addition to two diphenhydramine 25mg tablets. Patient was given a bottle of water. Over the course of approximately 7 minutes she consumed about one-half of the bottle. Paramedics were called. Prior to their arrival at 9:47 AM, the patient experienced additional swelling of lips, this time the top, and labored breathing. Another Epi-Pen was administered. Patient reported some elevated heart rate and mild headache, probably as a result of the epinephrine administration. She was transported to hospital at 9:49 AM.
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| 59 | 2021-03-30 | eye swelling |
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;...
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When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
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| 59 | 2021-03-30 | ear discomfort, ear pain |
coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild alle...
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coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 59 | 2021-03-30 | swelling of eyelid |
sore right eyelid; eyelid more swollen/right eyelid is much more swollen, red, and droopy; right eye...
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sore right eyelid; eyelid more swollen/right eyelid is much more swollen, red, and droopy; right eyelid is much more swollen, red, and droopy; right eyelid is much more swollen, red, and droopy; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9265), via an unspecified route of administration on arm Left on 05Feb2021 15:15 at single dose for COVID-19 immunisation at workplace clinic. Medical history included Chronic reactivated Epstein Barr Virus and Cytomegalovirus. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, the patient woke up Saturday on 06Feb2021 with sore right eyelid. Looked for evidence of stye but could not identify. Sunday, on 07Feb2021 eyelid more swollen, still no evidence of stye. Monday, on 08Feb2021, right eyelid was much more swollen, red, and droopy. Cannot locate a stye. Patient was treating with hot compresses. All the events were occurred on 06Feb2021 at 07:00 AM. The patient not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.
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| 59 | 2021-03-31 | ringing in ears | Severe Tinnitus constant ringing in ears, getting worse |
| 59 | 2021-04-01 | ringing in ears, deafness |
Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontane...
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Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included DM (diabetes mellitus) and HTN (hypertension) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 11:30, the patient experienced hearing loss with tinnitus to right ear. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The events was treated with hyperbaric oxygen therapy. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event hearing loss with tinnitus cannot be completely excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-04-02 | ringing in ears, deafness |
Severe Tinnitus, slight hearing loss, accompanying severe headache - tinnitus has persisted for thr...
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Severe Tinnitus, slight hearing loss, accompanying severe headache - tinnitus has persisted for three weeks, unabated.
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| 59 | 2021-04-03 | mouth tingling, eye itchiness, inability to speak, ringing in ears |
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li...
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eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-04-04 | ear discomfort, ringing in ears |
Telephone call received from client who reports she received vaccine yesterday and is now having a ...
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Telephone call received from client who reports she received vaccine yesterday and is now having a sore arm and pressure in her ears. Also stated she had sinus infection for a month. Having buzzing in her ears but not sure if buzzing or "shot:. Stated at work at time of this report and just wanted to report.
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| 59 | 2021-04-05 | eye swelling | anaphylaxis response Swelling of neck/face/eyes, difficulty in breathing |
| 59 | 2021-04-06 | deafness unilateral, ringing in ears, hearing loss, burning mouth syndrome, ear pain |
Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional h...
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Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional heart palpitations that lasted first 4 days then stopped--heart returned to normal with no more episodes. On 2/4/21, that night when I went to bed, I noticed a ringing in my left ear that became louder & louder as the next several days went by. I then noticed substantial hearing loss in my left ear. Also 2 days later, I started having a dull ache around my left ear along with the loud, high pitched ringing. I kept thinking it would get better but a week before my next vaccine, I called my ENT who monitors a small lesion & hearing in my left middle ear. I already had slight conductive hearing loss from this lesion and my last appointment/check up with her was in September 2020. Dr. had me come to the hospital on 3/11/21 and a hearing test was performed and my left ear hearing had declined 15 decibels since my last hearing test in Sept 2020. I was prescribed a Medrol Pak (steroids) for 1 week and returned on 3/23 for a 2nd hearing test with no improvement in my hearing or the loud ringing (tinnitus). The Dr. told me that my hearing test showed damage to the left ear nerve. I had also developed an inflamed, painful large sore under the left side of my tongue & was prescribed Triamcinolone Acetonide Dental Paste to use 2 x daily on the sore. The Dr. ordered an MRI of my brain & left ear to make sure the lesion in my ear had not grown. I had the MRI on 3/29/21 and returned to my Dr. on 3/30/21 for results. The lesion was stable, no growth. I made my own decision and did not return for my 2nd Covid vaccine because it appears the 1st vaccine either inflamed the nerve in my ear or caused an auto immune response.
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| 59 | 2021-04-10 | ringing in ears |
Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus al...
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Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus already in right ear. This is new and started the day after recieving the injection.
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| 59 | 2021-04-10 | mouth numbness |
nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; th...
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nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; throat felt swollen; Bell's palsy; lightheaded and dizzy; This is a spontaneous report received from a contactable consumer (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in the left arm, on 11Mar2021 15:30, as single dose, for covid-19 immunisation. Medical history included known allergies to antihistamine (unspecified) and sulfur drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); omeprazole; and anastrozole, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 59 years, via an unspecified route of administration in the left arm, on 18Feb2021 15:45, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 11Mar2021 at 15:45, 15 minutes after the second dose, the patient got lightheaded and dizzy. On the same day at 16:15, 45 minutes after the second dose, the patient experienced nerve problems behind left eye, then nerve problems in face, then lips had nerve problems, then tongue was numb, and throat felt swollen. The patient reported the side effects on the hotline, and she was transferred to a nurse who told her to go to the emergency room immediately as she could be getting Bell's palsy from the vaccine. The events resulted to emergency room visit and hospitalization (unspecified date in Mar2021). Treatment for the events included unspecified IV. The patient was hooked up to an EKG and her blood was drawn for checking in Mar2021 (results were unknown). The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
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| 59 | 2021-04-11 | vision blurred, visual impairment, eye floaters |
Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had ...
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Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had severe weakness of the right arm starting the day after the immunization, headaches across the whole head, severe fatigue, confusion (brain fog), worsening depression, body aches, and these all progressed and got worse for at least 14 days. She was unable to work any of those days due to weakness, confusion, and body aches. She saw me in the clinic on March 2 as she was still feeling weak, tired, confused. The clinic notes that day record: "On the next day, the 26th, she had severe pain and couldn't do much. Then she got super depressed and could not get out of bed for 2 weeks, had a lot of fatigue, body aches, and felt down. She tried going to the store one day and by the time she got done she could not get into her truck because she was in so much pain. That would have been about 2 weeks ago. She went back to work last week and was at work the whole week. She was told she does have leave time and that it did not cover the absence of work. She now needs new leave time forms completed. Currently she is in a lot of pain. She has her endocrine appointment on March 15th. The pain is getting worse. The cold is really hard on her. She is barely able to move her right arm at the end of the day, and that is the arm where she had the COVID shot. She is having a lot more weakness. She can not even take one flight of stairs now because everything hurts her. This is a huge difference than before. She used to be able to do several flights, and she can't do that anymore. She has also had vision changes. She has floaters but she is having a harder time focusing. She feels like no one would believe her, but she feels like this is all part of the reaction to COVID. She has a hard time focusing. She feels like she is going insane."
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| 59 | 2021-04-15 | vision blurred |
After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dos...
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After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dose on 25 Mar, patient was feeling tired, and described mental capacity as being foggy. Lost apatite and wanted to sleep. Described vision as blurry and couldn't focus.
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| 59 | 2021-04-17 | ear pain, lip swelling, swollen tongue |
she was in distress with her throat starting to swell, her tongue started to swell and she was cover...
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she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date. The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021. Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.
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| 59 | 2021-04-22 | bloodshot eyes, eye disorder |
Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure ...
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Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; Anxiety; Eye felt red; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: E10142), dose 1 via an unspecified route of administration, administered in left arm on 14jan2021 at 09:00 as single dose for covid-19 immunisation. Medical history included vitamin supplementation, supplementation therapy, cataract (Mother had cataracts; problems with her heart; had a couple of strokes before she died at 59 years of age), cardiac disorder, cerebrovascular accident, pain (Before she had the first dose of Pfizer COVID-19 Vaccine she was not so concerned because she figured she would probably get body aches or headaches, normal side effects), headache, normal side effects. Concomitant medications included ergocalciferol (vitamin d [ergocalciferol), krill oil (megared omega 3 krill oil), vitamin c [ascorbic acid], nigella sativa seed (black seed [nigella sativa seed]), betacarotene, calcium carbonate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, sodium ascorbate, thiamine hydrochloride, tocopheryl acetate (one-a-day vitamin), cyanocobalamin (vitamin b12 [cyanocobalamin]), acetylsalicylic acid (baby aspirin), calcium, magnesium, zinc (magnesium/calcium/zinc) taken for vitamin supplementation and probiotics taken for supplementation therapy. No any other vaccinations within 4 weeks Prior to the first administration. No AE(s) following prior vaccinations: although she did get unknown Shingles vaccine in Sep2020, no AEs associated. She has not gone to get the second Shingles vaccine because she does not want to overlap vaccines while getting Pfizer COVID-19 Vaccine. The patient Was concerned for her 2nd dose which she was scheduled to take tomorrow on 02Feb2021 at 14:30, because of the side effects from her 1st dose. On 15Jan2020, a day after the 1st dose, her heart started pumping really hard and she had a fast heartbeat/ heart fluttering a lot. She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye. She it was strange because this has never happened to her before up until she got the vaccine. She consulted her eye doctor and mentioned that she will be monitored for the pressure in her right eye. She is also getting anxiety because of this. She was asking if she can go tomorrow to take the 2nd shot. The outcome of events her heart started pumping really hard, she also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye, anxiety and eye felt red was unknow where the outcome of events fast heartbeat/heart fluttering a lot was not recovered. Follow-up attempts are completed. No further information is expected.
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| 59 | 2021-04-24 | ear discomfort, deafness unilateral, ringing in ears |
Right ear started popping; patient started to feel fullness in her right ear; right ear started high...
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Right ear started popping; patient started to feel fullness in her right ear; right ear started high pitched ringing ( tinnitus); She then lost hearing in her right ear; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (lot number: EN6207) at the age of 59 years old, as single dose for COVID-19 immunization. Medical history reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included hydrochlorothiazide, metoprolol tartrate (METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE); losartan; levothyroxine sodium (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. 2 days after 1st dose (17Mar2021 04:00), the patient started to feel fullness in her right ear. She thought at first perhaps it was water, but feeling continued. Right ear started popping a few days later. She called her primary care physician and made appointment to come in. Primary care could see nothing wrong, no inflammation in ear or fluid. That following weekend (Mar2021) after primary care visit, her right ear started high pitched ringing (tinnitus). She then lost hearing in her right ear. She went to urgent care who also saw nothing but referred her to ENT doctor. 2 days later at ENT audiologist reported significant hearing loss in her right ear. She is currently prescribed prednisone with no change. She never had a reaction to any shot ever previously. She also have never had any hearing issues or tinnitus ever in her life. The only time she had anything is from the Pfizer shot. She has been advised by her doctor to hold off on second dose. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient was not diagnosed with COVID prior and after vaccination. The patient has no known allergies. No other vaccines received four weeks prior to COVID vaccine. The patient has not recovered from the events.
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| 59 | 2021-04-26 | taste impairment |
A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficul...
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A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficulty breathing; had a horrific taste in my mouth; A nurse saw me in distress & caught me before I hit the floor; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 11Apr2021 at 11:15 (batch/lot number: EP7533) as a single dose for COVID-19 immunisation. Medical history included cancer history, back injury, right shoulder injury; and known allergies to sulfa, IVP dye, latex, bee stings and mushrooms. The patient was not pregnant. Facility type vaccine was health clinic. No other vaccine in four weeks. No Covid prior to vaccination and not Covid tested post vaccination. Concomitant medications in two weeks included gabapentin, valaciclovir, tramadol, doxycycline and vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, morphine and hydromorphone hcl (DILAUDID) and experienced known allergies to all drugs. On 11Apr2021 at 11:30, also reported as within 2 minutes of getting the vaccine, the patient had a horrific taste in her mouth followed by dizziness & lightheadedness. A nurse saw her in distress & caught her before she hit the floor. She then had difficulty breathing. They administered EpiPen, 50 mg liquid Benadryl & 2 puffs of Ventolin. She was transported to the ER by ambulance. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
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| 59 | 2021-04-27 | lip swelling | LIP SWELLING |
| 59 | 2021-04-27 | mouth discomfort, mouth swelling |
Patient called the pharmacy complaining of swelling inside of mouth, having spicy feeling, red in ap...
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Patient called the pharmacy complaining of swelling inside of mouth, having spicy feeling, red in apperance. It's not painful but uncomfortable according to the patient, can still taste, chew or eat normally. No ulcer or bleeding. Recommended the patient to start Benadryl right away at night to avoid drowsiness.
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| 59 | 2021-04-27 | loss of smell |
strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell...
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strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell; This is a spontaneous report from a contactable Nurse (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 14:00 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, asthma, diabetes. Known allergies: ranitidine/metformin. No pregnant. The patient's concomitant medications were not reported. No covid prior vaccination.No other vaccine in four weeks. Historical Vaccine included first dose bnt162b2 at 58 year old for covid-19 immunisation, first dose lot number=EN6199, administration date=10Mar2021, administration time=02:00 PM, vaccine location=Left arm and experienced headache, shortness of breath and body pain. The patient experienced strong headache, a lot of shortness of breath, lungs full of fluids, stomach sickness, lost of smell on 05Apr2021 with outcome of recovering. The event was serious due to life threatening. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Betamethasone 6mg/ml=3ml/ predinisone 40mg x 4. No covid tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021444473 Same patient, different shot/event
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| 59 | 2021-04-28 | eye disorder, eye pain |
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;...
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Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
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| 59 | 2021-05-04 | mouth numbness, taste impairment |
Immediately had strong metallic taste, accompanied by mild nausea. Began drinking lots of water, wh...
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Immediately had strong metallic taste, accompanied by mild nausea. Began drinking lots of water, which did help. Lips became numb, but did not swell, no difficulty breathing or tightness in chest. Symptoms were mild, so no treatment was needed., so I went home to rest and hydrate. Continued to drink lots of water. Felt very fatigued and lips were numb for 4-5 hours post vaccine.
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| 59 | 2021-05-05 | mouth tingling, lip swelling |
Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine ra...
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Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine rash on cheeks/chin and face swelling, roof of mouth felt slightly swollen and lips tingly feeling slightly swollen, pills felt stuck in back of throat. went back in facility they told me to take Benadryl and go to doctor or ER if it gets worse, took Benadryl and Zyrtec and started past allergic reactions protocol, up to 4 Zyrtec and 4 Allegra in a day and Benadryl as needed. QNasl. Saw nurse practitioner who added Pepcid 2times a day. Did this for 3 weeks pills still feel stuck at back of throat on and off in a day.
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| 59 | 2021-05-07 | ear discomfort, ringing in ears, deafness |
head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure...
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head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure (specifically left ear area, also mild hearing loss left ear); Tinnitus; loss of appetite; insomnia (still have tinnitus and ear pressure as well as insomnia); insomnia (still have tinnitus and ear pressure as well as insomnia); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 23Mar2021 12:45 (Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient was not pregnant. Not diagnosed with COVID prior vaccination. No concomitant medications received. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 02Mar2021 08:15 AM (Lot Number: EN6202) as single dose for COVID-19 immunization. The patient experienced headache, head pressure (specifically left ear area, also mild hearing loss left ear), tinnitus, loss of appetite, insomnia (still have tinnitus and ear pressure as well as insomnia) on 28Mar2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 30Mar2021. No treatment received for the events. The outcome of the events was not recovered. The event mild hearing loss left ear was considered as serious (medically significant). Facility type vaccine was Hospital. No other vaccine in four weeks.
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| 59 | 2021-05-09 | toothache, pain in jaw |
Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort...
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Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort. Day 3 Extreme burning in lower jaw with pain also similar to toothache and all teeth and lower jaw. Eventually extended throughout my neck and lower part of my head. Inhaling felt like stabbing in lower neck and a three and four.
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